natgillin/translations-raw huggingface dataset:
Mnenja agencije pa je treba objaviti takoj potem, ko se izdela znanstvena ocena.
However, the opinions of the Authority should be published as soon as the scientific assessment is completed.
Pojasniti je treba, da enostopenjski pristop ne zadržuje objave ocene tveganja posameznega encima.
It should be clarified that “single-step-approach” does not delay the publication of the risk assessment for individual enzymes.
(19) Živilske encime je treba stalno nadzorovati ter, kadar koli je treba, ponovno oceniti glede na spremenjene pogoje uporabe in nove znanstvene podatke.
(19) Food enzymes should be kept under continuous observation and should be re-evaluated whenever necessary in the light of changing conditions governing their use and new scientific information.
Ne glede na to jih je treba ponovno oceniti in razvrstiti vsaj vsakih deset let.
However, a fresh scientific evaluation and classification should be performed at least every 10 years.
(20) Ukrepe, potrebne za izvajanje te uredbe, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil 1 .
(20) The measures necessary for the implementation of this Regulation should be 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 1 .
(20) Ukrepe, potrebne za izvajanje te uredbe, je treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil 1 .
(20) The measures necessary for the implementation of this Regulation 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 1 .
Ta predlog spremembe je potreben zato, da se besedilo uskladi z določbami novega sklepa o komitologiji.
This amendment is needed to align the text to the provisions of the new comitology decision.
ČLEN 2, ODSTAVEK 2, TOČKA (C A)new
ARTICLE 2, PARAGRAPH 2, POINT (C A) (new)
(ca) sredstev za pospešitev prebave ;
(ca) digestive aids ;
ČLEN 2, ODSTAVEK 4
ARTICLE 2, PARAGRAPH 4
Ta uredba ne velja za mikrobiološke kulture, ki se tradicionalno uporabljajo v proizvodnji živil in ki lahko vsebujejo encime, vendar se ne uporabljajo izrecno za njihovo proizvodnjo.
This Regulation shall not apply to microbial cultures that are traditionally used in the production of food and which may contain enzymes but which are not specifically used to produce them.
Ta uredba ne velja za :
This Regulation shall not apply to :
(a) mikrobiološke kulture, ki se uporabljajo v proizvodnji živil in ki lahko naključno proizvedejo encime, vendar se ne uporabljajo izrecno za njihovo proizvodnjo ;
(a) microbial cultures that are used in the production of food and which may incidentally produce enzymes but which are not specifically used to produce them;
(b) encime, namenjene neposredno za prehrano ljudi, kot so encimi za prehranske namene ali tisti, ki se uporabljajo kot prebavni encimi.
(b) enzymes intended for direct human consumption, such as enzymes for nutritional purposes or enzymes used as digestive aids.
Komisija je potrdila, da področje uporabe te uredbe ne velja za encime, namenjene za prehrano ljudi, kot so encimi za prehranske namene ali tisti, ki se uporabljajo kot prebavni encimi.
The Commission has confirmed that the scope of this regulation shall not apply to enzymes intended for human consumption such as enzymes for nutritional purposes or enzymes used as digestive aids.
To izhaja iz uvodne izjave 4 predloga Komisije.
This is covered by Recital 4 of the Commission's proposal.
Zaradi nedvoumnosti pa je treba na to opomniti v normativnem delu predlagane uredbe.
However, in order to make this clear, a reference is need within the main text of the proposed regulation.
Najprimernejše mesto za to pojasnilo je člen 2(4).
Article 2.4 is the most appropriate place to make such a reference.
Črtanje besede "tradicionalno" je pravno pojasnilo, saj njen pomen ni jasen.
The deletion of word "traditionally" is a legal clarification, as it is not clear what it means.
Po potrebi se lahko v skladu s postopkom iz člena 16(2) odloči, ali neka snov spada na področje uporabe te uredbe ali ne.
Where necessary, it may be decided in accordance with the procedure referred to in Article 16(2) whether or not a given substance falls within the scope of this Regulation.
Po potrebi se lahko v skladu z regulativnim postopkom s pregledom iz člena 16(2a) odloči, ali neka snov spada na področje uporabe te uredbe ali ne.
Where necessary, it may be decided in accordance with the regulatory procedure with scrutiny referred to in Article 16(2a) whether or not a given substance falls within the scope of this Regulation.
Uporablja se tudi naslednja opredelitev :
The following definition shall also apply:
Uporabljajo se naslednje opredelitve :
The following definitions shall apply:
(1) „encim“ je vsak protein rastlinskega, živalskega ali mikrobiološkega izvora, ki je zmožen katalizirati specifično biokemijsko reakcijo, ne da bi medtem spremenil svojo lastno strukturo; za namene te uredbe mora opredelitev vsebovati tudi „proencime”, to so spojine, ki so neaktivne ali skoraj neaktivne predhodnice encimov in se lahko ob določeni katalitski spremembi pretvorijo v aktivne encime;
(1) ‘enzyme’ means any protein of vegetable, animal or microbial origin, capable of catalysing a specific biochemical reaction, without changing its own structure in the process; this definition should for the purposes of this Regulation also include "pro-enzymes", i.e. compounds that are inactive or nearly inactive precursors of enzymes and can be converted to active enzymes if subjected to a specific catalytic change;
„živilski encim“ je proizvod, pridobljen z ekstrakcijo iz rastlin ali živali ali s postopkom vrenja z uporabo mikroorganizmov:
‘food enzyme’ means a product obtained by extraction from plants or animals or by a fermentation process using micro-organisms:
(2) „živilski encim“ je proizvod, pridobljen z ekstrakcijo iz rastlin , živali , mikroorganizmov ali njihovih proizvodov ali s postopkom vrenja z uporabo mikroorganizmov:
(2) ‘food enzyme’ means a product obtained by extraction from plants , animals , micro-organisms or products thereof, or by a fermentation process using micro-organisms:
(a) ki vsebujejo enega ali več encimov, ki lahko katalizirajo posebne biokemične reakcije; in
(a) containing one or more enzymes capable of catalyzing a specific biochemical reaction; and
(b) ki se dodajo živilom za opravljanje tehnološke funkcije v proizvodnji, predelavi, pripravi, obdelavi, pakiranju, prevozu ali skladiščenju živil.
(b) added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of foods.
(b) ki se dodajo živilom za opravljanje tehnološke funkcije v proizvodnji, predelavi, pripravi, obdelavi, pakiranju, prevozu ali skladiščenju živil ;
(b) added to food to perform a technological function in the manufacture, processing, preparation, treatment, packaging, transport or storage of foods;
(3) „pripravek živilskega encima“ je formulacija, ki sestoji iz enega ali več živilskih encimov, v katero se vmešajo snovi, kot so aditivi za živila in/ali druge živilske sestavine, ki lajšajo njihovo skladiščenje, prodajo, standardizacijo, redčenje ali raztopitev;
(3) ‘food enzyme preparation’ means a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution;
(4) „proizveden z GSO” pomeni pridobljen z uporabo gensko spremenjenega organizma kot zadnjega živega organizma v proizvodnem procesu, vendar ne vsebuje in ne sestoji iz gensko spremenjenih organizmov, niti ni iz njih proizveden;
(4) ‘produced by GMOs’ means derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs ;
(5) „quantum satis” pomeni 1 , da mejna vrednost ni določena.
(5) ‘quantum satis’ means 1 that no maximum level is specified.
Ne glede na to se aditivi v skladu z dobro proizvodno prakso uporabljajo v količini, ki ni višja od tiste, ki je potrebna za doseganje predvidenega namena, in pod pogojem, da se ne zavaja potrošnika.
However, additives shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled.
1 Besedilo iz člena 2(5) Direktive 94/35/ES (o sladilih).
1 Text from Article 2(5) of Directive 94/35/EC (sweeteners).
Predstave o tem, kaj pomeni izraz „ encim “ , se lahko razlikujejo.
There may be different perceptions of what is meant by the term 'enzyme'.
V nekaterih primerih se uporablja za čisti encimski protein, v drugih pa za opis proizvoda, dobljenega z ekstrakcijo ali vrenjem, ki ne vključuje samo encimskega proteina, ampak tudi ostanke iz tega postopka.
In some cases the term is used to describe the pure enzyme protein, whereas in others it is used to describe the product obtained by extraction or fermentation which does not only include the enzyme protein, but also some residues from the process.
Izraz encim pa se lahko uporablja tudi za končni proizvod, namenjen prodaji, ki so mu bile dodane druge sestavine.
Finally, the term enzyme may also be used to describe the ready-to-sell product to which other ingredients have been added.
Zaradi pravne gotovosti in strokovne doslednosti so za razlikovanje med omenjenimi tremi primeri potrebne različne opredelitve.
For the sake of legal certainty and good science, separate definitions are needed to distinguish between these three situations.
To je potrebno zaradi večje popolnosti, da bo zajeta tudi možnost uporabe proencimov, ki niso encimi, temveč predhodniki encimov, v pripravi živil.
This is necessary for the sake of completeness in order to cover the possibility of the use of pro-enzymes, which are not enzymes but precursors to enzymes, in food preparation.
Da ne bi prišlo do nedosledne uporabe izrazja, mora biti uredba skladna z opredelitvami GSO v drugi zakonodaji, ki se nanaša na to področje.
The regulation should be consistent with GMO definitions used in other relevant legislation in order not to confuse terminology.
Quantum satis: Opredelitev izraza „quantum satis“ iz člena 12(f) je treba vključiti v ta člen skupaj z ostalimi opredelitvami.
Quantum satis: A definition for ‘quantum satis’, referred to in Article 12 (f), should be included in this article with the other definitions.
ČLEN 4, ODSTAVEK 1 A (NEW)
ARTICLE 4, PARAGRAPH 1 A (NEW)
Nihče ne daje v promet živilskega encima ali živila, ki tak encim vsebuje, če uporaba tega encima ni v skladu s to uredbo.
No person shall place on the market a food enzyme or any food in which such a food enzyme is present if the use of the food enzyme does not comply with this Regulation.
Ta nova točka zagotavlja, da so v uredbi zajeti vsi primerni živilski encimi.
This new point ensures that all eligible food enzymes are covered by this Regulation.
Živilski encim se lahko vključi v seznam Skupnosti, le če izpolnjuje naslednje pogoje:
A food enzyme may be included in the Community list only if it meets the following conditions:
a) na podlagi razpoložljivih znanstvenih dokazov uporaba v predlaganih količinah ne predstavlja tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed;
a) na podlagi razpoložljivih znanstvenih dokazov in previdnostnega načela uporaba v predlaganih količinah ne predstavlja tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available and the precautionary principle , pose a safety concern to the health of the consumer at the level of use proposed;
(b) obstaja razumna tehnološka potreba;
(b) there is a reasonable technological need;
(c) njegova uporaba ne zavaja potrošnika.
(c) its use does not mislead the consumer.
(c) njegova uporaba ne zavaja potrošnika ; zavajanje potrošnika vključuje, vendar se ne omejuje na vidike, povezane z naravo, svežostjo in kakovostjo uporabljenih sestavin, naravnostjo proizvoda ali proizvodnega procesa, hranilno vrednostjo proizvoda ali vsebnostjo sadja in zelenjave;
(c) its use does not mislead the consumer ; misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, the nutritional quality of the product or the fruit and vegetable content;
(ca) njegova uporaba prinaša potrošniku nedvomno korist.
(ca) its use has a clear benefit for the consumer.
Kot v obstoječi zakonodaji o aditivih za živila mora biti nedvomna korist za potrošnika v postopku odobritve živilskih encimov eden bistvenih pogojev.
As in the current legislation on food additives, a clear benefit for the consumer must be a central requirement in the authorisation process for food enzymes.
Predlog spremembe je potreben zaradi boljše splošne razumljivosti besedne zveze „zavajanje potrošnika”.
There should be an improved common understanding of the meaning of the phrase ‘misleading the consumer'.
ČLEN 6, ODSTAVEK 2, TOČKA (A)
ARTICLE 6, PARAGRAPH 2, POINT (A)
(a) ime živilskega encima;
(a) the name of the food enzyme;
(a) opredelitev živilskega encima , vključno s splošnim ali priporočenim imenom, sistematičnim imenom in sopomenkami, po možnosti v skladu z nomenklaturo Mednarodnega združenja za biokemijo in molekularno biologijo, v primeru zapletenih encimov pa z imenom, izbranim na podlagi delovanja encima, ki določa njegovo funkcijo ;
(a) the definition of the food enzyme , including its common or recommended name, systematic name and synonyms, if possible according to the nomenclature of the International Union of Biochemistry and Molecular Biology and, in the case of complex enzymes, selected on the basis of the enzyme activity that determines the enzyme's function ;
Uporabiti bi bilo treba najnatančnejše ime encima, ki temelji na nomenklaturi Mednarodnega združenja za biokemijo in molekularno biologijo.
If possible, the most accurate enzyme name, based on the International Union of Biochemistry (IUB)'s Nomenclature should be used.
Pri zapletenih encimih bi moralo biti ime izbrano na podlagi delovanja encima (aktivna sestavina), ki opravlja funkcijo pri predelavi živil.
In cases of complex enzymes, the name should be based on the enzyme activity (active principle) that is exerting the functionality in the food processing.
ČLEN 6, ODSTAVEK 2, TOČKA (B)
ARTICLE 6, PARAGRAPH 2, POINT (B)
(b) specifikacije živilskega encima, vključno z izvorom, merili čistosti in drugimi potrebnimi podatki; če živilski encim spada v področje uporabe Uredbe (ES) št. 1830/2003, se v specifikacije vključi navedba posebne identifikacijske oznake, dodeljene gensko spremenjenemu organizmu v skladu z navedeno uredbo;
(b) the specifications of the food enzyme, including its origin, purity criteria and any other necessary information; where the food enzyme falls within the scope of Regulation (EC) No 1830/2003, a reference to the unique identifier attributed to the genetically modified organism pursuant to that Regulation shall be included in the specifications;
(b) specifikacije živilskega encima, vključno z izvorom, merili čistosti in drugimi potrebnimi podatki; če se živilski encim pridobi iz organizma, ki spada v področje uporabe Uredbe (ES) št. 1830/2003, se v specifikacije vključi navedba posebne identifikacijske oznake, dodeljene gensko spremenjenemu organizmu v skladu z navedeno uredbo;
(b) the specifications of the food enzyme, including its origin, purity criteria and any other necessary information; where the food enzyme is derived from an organism falling within the scope of Regulation (EC) No 1830/2003, a reference to the unique identifier attributed to the genetically modified organism pursuant to that Regulation shall be included in the specifications;
Zahteva, da je treba gensko spremenjene živilske encime odobriti v skladu z Uredbo (ES) 1829/2003, še preden se ocenijo zaradi vključitve v seznam Skupnosti predlagane uredbe o živilskih encimih, je v nasprotju z zgoraj omenjenim pristopom in bi lahko privedla do dveh ločenih postopkov odobritve encimov.
The requirement for a GM derived food enzyme to be authorised in accordance with 1829/2003 before it may be assessed for inclusion in the Community list of the proposed food enzymes Regulation appears to go against this approach and may result in the enzyme having to undergo two separate authorisation procedures.
ČLEN 6, ODSTAVEK 2, TOČKE (C) DO (F)
ARTICLE 6, PARAGRAPH 2, POINTS (C) TO (F)
(c) po potrebi živila, katerim se živilski encim lahko doda;
(c) if necessary, the foods to which the food enzyme may be added;
(c) živila, katerim se živilski encim lahko doda;
(c) the foods to which the food enzyme may be added;
(d) po potrebi pogoje, v skladu s katerimi se živilski encim lahko uporablja;
(d) if necessary, the conditions under which the food enzyme may be used;
(d) pogoje, v skladu s katerimi se živilski encim lahko uporablja;
(d) the conditions under which the food enzyme may be used;
(e) če je ustrezno, ali obstajajo kakršne koli omejitve v zvezi s prodajo živilskega encima neposredno potrošniku;
(e) if appropriate, whether there are any restrictions on the sale of the food enzyme directly to consumers;
(f) po potrebi posebne zahteve v zvezi z označevanjem živil, v katerih so živilski encimi, zato da se zagotovi obveščenost končnega potrošnika o fizikalnem stanju živila ali o posebni obdelavi živila.
(f) where necessary, specific requirements in respect of the labelling of food in which the food enzymes have been used in order to ensure that the final consumer is informed of the physical condition of the food or the specific treatment it has undergone.
(f) posebne zahteve v zvezi z označevanjem živil, v katerih so živilski encimi, zato da se zagotovi obveščenost končnega potrošnika o fizikalnem stanju živila ali o posebni obdelavi živila.
(f) specific requirements in respect of the labelling of food in which the food enzymes have been used in order to ensure that the final consumer is informed of the physical condition of the food or the specific treatment it has undergone.
Vključitev gensko spremenjenih encimov v seznam Skupnosti
Inclusion of genetically modified enzymes on the Community list
Vključitev encimov, pridobljenih iz gensko spremenjenih organizmov (GSO), v seznam Skupnosti
Inclusion of enzymes derived from genetically modified organisms (GMOs) on the Community list
Živilski encim, ki spada na področje uporabe Uredbe (ES) št. 1829/2003, se lahko vključi v seznam Skupnosti po odobritvi v skladu s postopkom iz člena 7 navedene uredbe.
A food enzyme falling within the scope of Regulation (EC) No 1829/2003 may be included in the Community list only after it has been authorised in accordance with the procedure referred to in Article 7 of that Regulation.
Brez poseganja v člen 4 te uredbe se lahko živilski encim, pridobljen iz organizma, ki spada na področje uporabe Uredbe (ES) št. 1829/2003, se lahko vključi v seznam Skupnosti po odobritvi v skladu s postopkom iz člena 7 navedene uredbe.
Without prejudice to Article 4 of this Regulation, a food enzyme derived from an organism falling within the scope of Regulation (EC) No 1829/2003 may only be included in the Community list once it has been authorised in accordance with the procedure referred to in Article 7 of that Regulation.
Živilski encimi, ki niso namenjeni za prodajo končnemu potrošniku in ki se prodajo posamično ali v mešanici z drugimi encimi in/ali z drugimi sestavinami, kot je opredeljeno v členu 6(4) Direktive 2000/13/ES , se lahko tržijo le, če so na embalaži ali posodi navedeni podatki iz členov 9 do 12 te uredbe , ki morajo biti dobro vidni, jasno berljivi in neizbrisni.
Food enzymes not intended for sale to the final consumer, whether sold singly or mixed with each other and/or with other ingredients as defined in Article 6(4) of Directive 2000/13/EC, may be marketed only where the packaging or containers bear the information provided for in Articles 9 to 12 of this Regulation, which must be easily visible, clearly legible and indelible.
Živilski encimi in pripravki živilskih encimov , ki niso namenjeni za prodajo končnemu potrošniku in ki se prodajo posamično ali v mešanici z drugimi encimi, se lahko tržijo le, če so na embalaži ali posodi navedeni podatki iz tega člena , ki morajo biti dobro vidni, jasno berljivi in neizbrisni.
Food enzymes and food enzyme preparations not intended for sale to the final consumer, whether sold singly or mixed with each other, may be marketed only where the packaging or containers bear the information provided for in this Article , which must be easily visible, clearly legible and indelible.
Na embalaži ali posodah so navedeni naslednji podatki:
The packaging or containers shall provide the following information:
(a) ime, določeno v tej uredbi, in opis v skladu z nomenklaturo Mednarodnega združenja za biokemijo in molekularno biologijo; in
(a) the name laid down in this Regulation, and the description according to the nomenclature of the International Union of Biochemistry and Molecular Biology; and
(b) opis živilskega encima, ki je dovolj natančen, da se živilski encim razlikuje od proizvodov, s katerimi bi ga lahko zamenjali.
(b) a description of the food enzyme that is sufficiently precise to distinguish it from products with which it could be confused.
Kadar se živilski encimi ali pripravki živilskih encimov prodajajo v mešanici z drugimi, so podatki iz točke (a) ali (b) navedeni za vsak živilski encim v padajočem vrstnem redu glede na njegov utežni odstotek celote;
Where food enzymes or food enzyme preparations are sold mixed with each other, the information provided for in point (a) or (b) shall be given in respect of each food enzyme, in descending order of its percentage by weight of the total;
(c) neto količina;
(c) the net quantity;
(d) rok trajanja, po katerem bi bila uporaba živilskega encima neprimerna;
(d) the expiry date beyond which use of the food enzyme would be inappropriate;
(e) navedba „za uporabo v živilih“ ali „omejena uporaba v živilih“ ali podrobnejši opis namena uporabe v živilih;
(e) the statement either ‘for use in food' or ‘restricted use in food’ or a more specific reference to its intended food use;
(f) po potrebi posebni pogoji prevoza, shranjevanja in uporabe;
(f) if necessary, the special conditions of transport, storage and use.
Poleg tega se na embalaži ali posodi ali v spremnih dokumentih, ki so poslani pred dobavo ali hkrati z njo, navedejo naslednji podatki, pod pogojem, da je navedba „namenjeno za proizvodnjo živil in ne za prodajo na drobno“ vidna na embalaži ali posodi zadevnega proizvoda:
In addition, the following information shall be provided, either on the packaging or container, or in the documents relating to the product which are to be supplied with or prior to the delivery, on condition that the indication "intended for the manufacture of food and not for retail sale" is visible on the packaging or container of the product in question:
(a) ime ali naziv podjetja ter naslov proizvajalca, izvajalca pakiranja ali prodajalca s sedežem v Skupnosti;
(a) the name or business name and address of the manufacturer or packager, or of a seller established within the Community;
(b) oznaka serije ali lota;
(b) a mark identifying the batch or lot;
(c) navodila za uporabo, če bi se sicer brez njih živilski encim lahko uporabil nepravilno;
(c) directions for use, if the omission thereof would preclude appropriate use of the food enzyme;