natgillin/translations-raw huggingface dataset:
In order to ensure harmonisation, the risk assessment of food enzymes and their inclusion in the Community list should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [8].
Da se zagotovi usklajenost, bi bilo treba opraviti oceno tveganja encimov za živila in jih vključiti v seznam Skupnosti v skladu s postopkom iz Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila [8].
Under 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 [9], the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health.
V skladu 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 [9], se je treba z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu „Agencija“) posvetovati o zadevah, ki lahko vplivajo na javno zdravje.
A food enzyme which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [10] should be authorised in accordance with that Regulation as well as under this Regulation.
Encim za živila, ki spada na področje uporabe Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi [10], bi bilo treba odobriti v skladu z navedeno uredbo in v skladu s to uredbo.
A food enzyme already included in the Community list under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the authorisation and the specifications under this Regulation, should be submitted for evaluation by the Authority.
Encim za živila, ki je že vključen v seznam Skupnosti v skladu s to uredbo in je pridobljen s proizvodnimi metodami ali z uporabo vhodnih sestavin, ki se znatno razlikujejo od tistih, ki so vključene v oceno tveganja Agencije, ali od tistih, za katere veljajo odobritev in specifikacije po tej uredbi, bi bilo treba predložiti Agenciji v oceno.
‘Significantly different’ could mean inter alia a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size.
„Znatna različnost“ bi lahko med drugim pomenila spremembo proizvodne metode iz izvlečkov iz rastlin v proizvodnji s fermentacijo z uporabo mikroorganizma ali gensko spremenjenega prvotnega mikroorganizma, spremembo vhodnih sestavin ali spremembo velikosti delcev.
Since many food enzymes are already on the Community market, provision should be made to ensure that the switchover to a Community list of food enzymes takes place smoothly and does not disturb the existing food enzyme market.
Ker so številni encimi za živila že na trgu Skupnosti, bi bilo treba zagotoviti, da bo prehod na seznam Skupnosti encimov za živila potekal nemoteno in ne bo oviral obstoječega trga z encimi za živila.
Sufficient time should be allowed for applicants to make available the information necessary for the risk assessment of these products.
Predlagateljem bi bilo treba dati dovolj časa, da zagotovijo informacije, potrebne za pripravo ocene tveganja teh izdelkov.
An initial two-year period should therefore be allowed following the date of application of the implementing measures to be laid down in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], in order to give applicants sufficient time to submit the information on existing enzymes which may be included in the Community list to be drawn up under this Regulation.
Na podlagi tega bi bilo treba po začetku uporabe izvedbenih ukrepov, ki se določijo v skladu z Uredbo (ES) št. 1331/2008, dovoliti začetno dveletno obdobje, da bi imeli predlagatelji dovolj časa za predložitev informacij o obstoječih encimih, ki se lahko vključijo v seznam Skupnosti, pripravljen v skladu s to uredbo.
It should also be possible to submit applications for the authorisation of new enzymes during the initial two-year period.
Treba bi bilo omogočiti tudi predložitev vlog za odobritev novih encimov v začetnem dveletnem obdobju.
The Authority should evaluate without delay all applications for food enzymes for which sufficient information has been submitted during that period.
Agencija bi morala nemudoma podati oceno za vse vloge za encime za živila, za katere so bili v navedenem obdobju predložene zadostne informacije.
In order to ensure fair and equal conditions for all applicants, the Community list should be drawn up in a single step.
Da bi za vse predlagatelje veljali pošteni in enaki pogoji, bi bilo treba seznam Skupnosti pripraviti v enem koraku.
That list should be established after completion of the risk assessment of all food enzymes for which sufficient information has been submitted during the initial two-year period.
Ta seznam bi bilo treba vzpostaviti po opravljeni oceni tveganja vseh encimov za živila, za katere so bili v začetnem dveletnem obdobju predložene zadostne informacije.
However, the risk assessments of the Authority for individual enzymes should be published as soon as they are completed.
Ocene tveganja Agencije za posamezne encime pa bi bilo treba objaviti takoj po tem, ko se take ocene opravijo.
A significant number of applications is expected to be submitted during the initial two-year period.
V začetnem dveletnem obdobju se pričakuje veliko število vlog.
A lengthy period may therefore be needed before the risk assessment of these has been completed and the Community list is drawn up.
Zaradi tega naj bi potrebovali več časa, da se opravijo vse ocene tveganja in pripravi seznam Skupnosti.
In order to ensure equal access to the market for new food enzymes after the initial two-year period, a transitional period should be provided for during which food enzymes and food using food enzymes may be placed on the market and used, in accordance with the existing national rules in the Member States, until the Community list has been drawn up.
Da bi po začetnem dveletnem obdobju zagotovili enak dostop do trga za nove encime za živila, bi bilo treba določiti prehodno obdobje, v katerem se lahko encimi za živila in živila z encimi za živila dajo v promet in uporabljajo v skladu z obstoječimi nacionalnimi pravili v državah članicah, dokler se ne pripravi seznam Skupnosti.
The food enzymes E 1103 Invertase and E 1105 Lysozyme, that have been authorised as food additives under Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners [11], and the conditions governing their use should be carried over from Directive 95/2/EC to the Community list when it is drawn up by this Regulation.
Encima za živila E 1103 invertaza in E 1105 lizocim, ki sta bila odobrena kot aditiva za živila v okviru Direktive 95/2/ES Evropskega parlamenta in Sveta z dne 20. februarja 1995 o aditivih za živila razen barvil in sladil [11], in pogoje, ki urejajo njuno uporabo, bi bilo treba prenesti iz Direktive 95/2/ES na seznam Skupnosti, ko bo ta pripravljen na podlagi te uredbe.
In addition, Council Regulation (EC) No 1493/1999 authorises the use of urease, beta-glucanase and lysozyme in wine subject to the conditions laid down in Commission Regulation (EC) No 423/2008 of 8 May 2008 on laying down certain detailed rules for implementing Council Regulation (EC) No 1493/1999 and establishing a Community code of oenological practices and processes [12].
Poleg tega se je z Uredbo Sveta (ES) št. 1493/1999 odobrila uporaba ureaze, beta glukanaze in lizocima v vinu v skladu s pogoji, določenimi v Uredbi Komisije (ES) št. 423/2008 z dne 8. maja 2008 o določitvi nekaterih podrobnih pravil za izvajanje Uredbe Sveta (ES) št. 1493/1999 in vzpostavitvi kodeksa Skupnosti na področju enoloških postopkov in obdelav [12].
Those substances are food enzymes and they should fall within the scope of this Regulation.
Te snovi so encimi za živila in bi morali spadati na področje uporabe te uredbe.
They should therefore also be added to the Community list when it is drawn up for their use in wine in accordance with Regulation (EC) No 1493/1999 and Regulation (EC) No 423/2008.
Za njihovo uporabo v vinu v skladu z Uredbo (ES) št. 1493/1999 in Uredbo (ES) št. 423/2008 bi jih bilo treba vključiti tudi na seznam Skupnosti, ko bo pripravljen.
Food enzymes remain subject to the general labelling obligations provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [13] and, as the case may be, in Regulation (EC) No 1829/2003 and in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms [14].
Za encime za živila še vedno veljajo splošne obveznosti označevanja iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [13] ter, odvisno od primera, Uredbe (ES) št. 1829/2003 oziroma Uredbe (ES) št. 1830/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in krme, proizvedenih iz gensko spremenjenih organizmov [14].
In addition, specific provisions on the labelling of food enzymes sold as such to the manufacturer or to the consumer should be contained in this Regulation.
Poleg teh bi bilo treba v tej uredbi določiti posebne določbe za označevanje encimov za živila, ki se kot taki prodajo proizvajalcu ali potrošniku.
Food enzymes are covered by the definition of food in Regulation (EC) No 178/2002 and are therefore, when used in food, required to be indicated as ingredients in the labelling of the food in compliance with Directive 2000/13/EC.
Encime za živila zajema opredelitev živil iz Uredbe (ES) št. 178/2002, zato jih je treba, ko se uporabijo v živilih, pri označevanju živil navesti kot sestavine v skladu z Direktivo 2000/13/ES.
Food enzymes should be designated by their technological function in food, followed by the specific name of the food enzyme.
Encime za živila bi bilo treba označiti glede na njihovo tehnološko funkcijo v živilu, temu naj bi sledilo značilno ime encima za živila.
However, provision should be made for a derogation from the provisions on labelling in cases where the enzyme performs no technological function in the final product but is present in the foodstuff only as a result of carry-over from one or more of the ingredients of the foodstuff or where it is used as a processing aid.
Ne glede na to bi bilo treba zagotoviti odstopanje od določb o označevanju za primere, ko encim v končnem izdelku nima tehnološke funkcije, ampak je v živilu prisoten le kot posledica prenosa iz ene ali več sestavin živila ali se uporabi kot pomožno tehnološko sredstvo v predelavi.
Directive 2000/13/EC should be amended accordingly.
Direktivo 2000/13/ES bi bilo zato treba ustrezno spremeniti.
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.
Encime za živila bi bilo treba stalno nadzorovati ter jih po potrebi ponovno oceniti glede na spreminjajoče se pogoje njihove uporabe in nove znanstvene informacije.
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 [15].
Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [15].
In particular the Commission should be empowered to adopt appropriate transitional measures.
Zlasti bi bilo Komisiji treba podeliti pooblastila za sprejetje ustreznih prehodnih ukrepov.
In order to develop and update Community law on food enzymes in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States.
Da bi se zakonodaja Skupnosti na področju encimov za živila razvijala in posodabljala na skladen in učinkovit način, je treba zbirati podatke, izmenjavati informacije in uskladiti delo med državami članicami.
For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process.
V ta namen bi bilo koristno izvesti študije za obravnavo posebnih vprašanj, da se olajša postopek odločanja.
It is appropriate that the Community finance such studies as part of its budgetary procedure.
Primerno je, da se Skupnosti dovoli financiranje takšnih raziskav iz lastnega proračuna.
The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [16].
Financiranje takih ukrepov zajema Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [16].
Member States are to carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004.
Države članice izvajajo uradni nadzor, da se v skladu z Uredbo (ES) št. 882/2004 doseže skladnost s to uredbo.
Since the objective of this Regulation, namely to lay down Community rules on food enzymes, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, 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 cilja te uredbe, in sicer določiti pravila Skupnosti o encimih za živila, države članice ne morejo zadovoljivo doseči in ker ta cilj zaradi enotnosti trga in visoke ravni varstva potrošnikov lažje doseže Skupnost, Skupnost lahko sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
This Regulation lays down rules on food enzymes used in foods, including such enzymes used as processing aids, with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.
Ta uredba določa pravila za encime za živila, ki se uporabljajo v živilih, vključno z encimi, ki se uporabljajo kot pomožna tehnološka sredstva, z namenom zagotoviti učinkovito delovanje notranjega trga in hkrati visoko raven varovanja zdravja ljudi in visoko raven varstva potrošnikov, vključno z zaščito interesov potrošnikov in poštenim ravnanjem v trgovini z živili, pri čemer se po potrebi upošteva varstvo okolja.
For those purposes, this Regulation provides for:
Za navedene namene ta uredba določa:
a Community list of approved food enzymes;
seznam Skupnosti odobrenih encimov za živila;
conditions of use of food enzymes in foods;
pogoje uporabe encimov za živila v živilih;
rules on the labelling of food enzymes sold as such.
pravila označevanja encimov za živila, ki se prodajajo kot taki.
This Regulation shall apply to food enzymes as defined in Article 3.
Ta uredba se uporablja za encime za živila, kakor so opredeljeni v členu 3.
This Regulation shall not apply to food enzymes when and insofar as they are used in the production of:
Ta uredba se ne uporablja za encime za živila, če in kolikor se uporabljajo v proizvodnji:
food additives falling within the scope of Regulation (EC) No 1333/2008 [on food additives];
aditivov za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1333/2008;
processing aids.
pomožnih tehnoloških sredstev.
This Regulation shall apply without prejudice to any specific Community rules concerning the use of food enzymes:
Ta uredba se uporablja brez poseganja v posebna pravila Skupnosti v zvezi z uporabo encimov za živila:
in specific foods;
v posebnih živilih;
for purposes other than those covered by this Regulation.
za namene, ki niso vključeni v to uredbo.
This Regulation shall not apply to microbial cultures that are traditionally used in the production of food and which may incidentally produce enzymes, but which are not specifically used to produce them.
Ta uredba se ne uporablja za mikrobiološke kulture, ki se tradicionalno uporabljajo v proizvodnji živil in ki lahko naključno proizvajajo encime, vendar se ne uporabljajo izrecno za njihovo proizvodnjo.
For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002, Regulation (EC) No 1829/2003 and Regulation (EC) No 1333/2008 [on food additives] shall apply.
V tej uredbi se uporabljajo opredelitve pojmov iz Uredbe (ES) št. 178/2002, Uredbe (ES) št. 1829/2003 in Uredbe (ES) št. 1333/2008.
The following definitions shall also apply:
Uporabljata se tudi naslednji opredelitvi:
‘food enzyme’ means a product obtained from plants, animals or micro-organisms or products thereof including a product obtained by a fermentation process using micro-organisms:
„encim za živilo“ pomeni izdelek, ki je pridobljen iz rastlin, živali ali mikroorganizmov ali iz njihovih izdelkov, in tudi izdelek, ki je pridobljen s postopkom fermentacije z uporabo mikroorganizmov in:
containing one or more enzymes capable of catalyzing a specific biochemical reaction; and
vsebuje enega ali več encimov, ki lahko katalizirajo posebne biokemične reakcije in
added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods;
se dodaja živilom za tehnološke namene na kateri koli stopnji proizvodnje, predelave, priprave, obdelave, pakiranja, prevoza ali hrambe živil.
‘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.
„pripravki z encimi za živila“ pomeni obliko, ki se sestoji iz enega ali več encimov za živila, v katero so vgrajene snovi, kot so aditivi za živila in/ali druge sestavine živil, zaradi lažje hrambe, prodaje, standardizacije, redčenja ali raztopitve.
COMMUNITY LIST OF APPROVED FOOD ENZYMES
SEZNAM SKUPNOSTI ODOBRENIH ENCIMOV ZA ŽIVILA
Community list of food enzymes
Seznam Skupnosti encimov za živila
Only food enzymes included in the Community list may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use provided for in Article 7(2).
Le encimi za živila, vključeni v seznam Skupnosti, se lahko dajo v promet kot taki in uporabljajo v živilih v skladu s specifikacijami in pogoji uporabe iz člena 7(2).
Prohibition of non-compliant food enzymes and/or non-compliant food
Prepoved neustreznih encimov za živila in/ali neustreznih živil
No person shall place on the market a food enzyme or any food in which such a food enzyme has been used if the use of the food enzyme does not comply with this Regulation and its implementing measures.
Nihče ne sme dati v promet encimov za živila ali živil, v katerih so bili uporabljeni takšni encimi, če uporaba teh encimov za živila ni v skladu s to uredbo in njenimi izvedbenimi ukrepi.
General conditions for inclusion of food enzymes in the Community list
Splošni pogoji za vključitev encimov za živila v seznam Skupnosti
A food enzyme may be included in the Community list only if it meets the following conditions and, where relevant, other legitimate factors:
Encim za živila se lahko vključi v seznam Skupnosti le, če izpolnjuje naslednje pogoje in po potrebi druge utemeljene dejavnike:
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;
na podlagi razpoložljivih znanstvenih dokazov v predlagani količini ne ogroža zdravja potrošnika;
there is a reasonable technological need, and
zanj obstaja razumna tehnološka potreba in
its use does not mislead the consumer.
njegova uporaba ne zavaja potrošnika.
Misleading the consumer includes, but is not limited to, issues related to the nature, freshness and quality of the ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product.
Zavajanje potrošnika vključuje med drugim zadeve, povezane z vrsto, svežostjo in kakovostjo uporabljenih sestavin, naravnostjo izdelka ali proizvodnega postopka ali prehransko kakovostjo izdelka.
The content of the Community list of food enzymes
Vsebina seznama Skupnosti encimov za živila
A food enzyme which complies with the conditions set out in Article 6 may, in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], be included in the Community list.
Encim za živila, ki izpolnjuje pogoje iz člena 6, se lahko v skladu s postopkom iz Uredbe (ES) št. 1331/2008 vključi v seznam Skupnosti.
The entry of a food enzyme in the Community list shall specify:
Vpis encima za živila v seznam Skupnosti vsebuje:
the name of the food enzyme;
ime encima za živila;
the specifications of the food enzyme, including its origin, purity criteria and any other necessary information;
specifikacije encima za živila, vključno s poreklom, merili čistosti in drugimi potrebnimi informacijami;
the foods to which the food enzyme may be added;
živila, katerim se encim za živila lahko doda;
the conditions under which the food enzyme may be used; where appropriate, no maximum level shall be fixed for a food enzyme.
pogoje, v skladu s katerimi se encim za živila lahko uporablja; če je primerno, se za aditiv za živila ne določi najvišja dovoljena vsebnost.
In that case, the food enzyme shall be used in accordance with the quantum satis principle;
V tem primeru se encim za živila uporabi v skladu z načelom quantum satis;
if appropriate, whether there are any restrictions on the sale of the food enzyme directly to the final consumer;
če je ustrezno, omejitve v zvezi z neposredno prodajo encima za živila končnemu potrošniku;
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.
po potrebi posebne zahteve glede označevanja živil, v katerih so encimi za živila, zato da se zagotovi obveščenost končnega potrošnika o fizikalnem stanju živila ali o posebni obdelavi živila.
The Community list shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].
Seznam Skupnosti se spremeni v skladu s postopkom iz Uredbe (ES) št. 1331/2008.