natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1935/2004 foresees that for ion exchange resins, rubbers and silicones specific measures can be adopted.
V Uredbi (ES) št. 1935/2004 je predvideno, da je mogoče za ionske izmenjevalne smole, gume in silikone sprejeti posebne ukrepe.
As those materials are composed of different substances than plastics and have different physico-chemical properties specific rules for them need to apply and it should be made clear that they are not within the scope of this Regulation.
Ker so ti materiali sestavljeni iz drugačnih snovi kot polimerni materiali in imajo drugačne fizikalno-kemijske lastnosti, je treba zanje uporabiti posebna pravila in jasno opredeliti, da ne spadajo na področje uporabe te uredbe.
Plastics are made of monomers and other starting substances which are chemically reacted to a macromolecular structure, the polymer, which forms the main structural component of the plastics.
Polimerni materiali so izdelani iz monomerov in drugih izhodnih snovi, ki se kemično vežejo na makromolekularno strukturo, polimer, ki je glavna strukturna komponenta polimernih materialov.
To the polymer additives are added to achieve defined technological effects.
Za doseganje opredeljenih tehnoloških učinkov se dodajajo polimerni aditivi.
The polymer as such is an inert high molecular weight structure.
Polimer je inertna struktura z visoko molsko maso.
As substances with a molecular weight above 1000 Da usually cannot be absorbed in the body the potential health risk from the polymer itself is minimal.
Ker telo snovi z molsko maso nad 1000 Da običajno ne more absorbirati, je morebitno tveganje za zdravje zaradi samega polimera zanemarljivo.
Potential health risk may occur from non- or incompletely reacted monomers or other starting substances or from low molecular weight additives which are transferred into food via migration from the plastic food contact material.
Morebitno tveganje za zdravje se lahko pojavi zaradi monomerov ali drugih izhodnih snovi, ki niso ali niso v celoti vezane, ali zaradi aditivov z nizko molsko maso, ki prehajajo v živila z migracijo iz polimernega materiala, namenjenega za stik z živili.
Therefore monomers, other starting substances and additives should be risk assessed and authorised before their use in the manufacture of plastic materials and articles.
Zato je treba oceniti tveganje v zvezi z monomeri, drugimi izhodnimi snovmi in aditivi ter jih odobriti, preden se uporabijo za proizvodnjo polimernih materialov in izdelkov.
The risk assessment of a substance to be performed by the European Food Safety Authority (hereinafter the Authority) should cover the substance itself, relevant impurities and foreseeable reaction and degradation products in the intended use.
Ocena tveganja snovi, ki jo mora opraviti Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija), mora zajeti samo snov, pomembne nečistoče ter predvidljive reakcijske in degradacijske produkte pri načrtovani uporabi.
The risk assessment should cover the potential migration under worst foreseeable conditions of use and the toxicity.
Ocena tveganja mora zajeti morebitno migracijo v najslabših predvidljivih okoliščinah za uporabo in strupenost.
Based on the risk assessment the authorisation should if necessary set out specifications for the substance and restrictions of use, quantitative restrictions or migration limits to ensure the safety of the final material or article.
Na podlagi ocene tveganja je treba ob odobritvi po potrebi določiti specifikacije snovi in omejitve uporabe, količinske omejitve ali mejne vrednosti migracije za zagotovitev varnosti končnega materiala ali izdelka.
No rules have yet been set out at EU level for the risk assessment and use of colorants in plastics.
Na ravni EU še niso bili sprejeti predpisi za oceno tveganja in uporabo barvil v polimernih materialih.
Therefore their use should remain subject to national law.
Zato za njihovo uporabo še naprej velja nacionalna zakonodaja.
Solvents used in the manufacture of plastics to create a suitable reaction environment are expected to be removed in the manufacturing process as they are usually volatile.
Pričakuje se, da se topila, ki se uporabljajo pri proizvodnji polimernih materialov za doseganje ustreznega reakcijskega okolja, odstranijo iz proizvodnega procesa, saj so običajno hlapna.
No rules have yet been set out at EU level for the risk assessment and use of solvents in the manufacture of plastics.
Na ravni EU še niso bili sprejeti predpisi za oceno tveganja in uporabo topil pri proizvodnji polimernih materialov.
Plastics can also be made of synthetic or natural occurring macromolecular structures which are chemically reacted with other starting substances to create a modified macromolecule.
Polimerni materiali so lahko sestavljeni tudi iz sintetičnih ali naravnih makromolekularnih struktur, ki se kemično vežejo z drugimi izhodnimi snovmi, pri čemer nastane modificirana makromolekula.
Synthetic macromolecules used are often intermediate structures which are not fully polymerised.
Uporabljene sintetične makromolekule so pogosto vmesne strukture, ki niso v celoti polimerizirane.
Potential health risk may occur from the migration of non- or incompletely reacted other starting substances used to modify the macromolecule or an incompletely reacted macromolecule.
Tveganje za zdravje se lahko pojavi zaradi migracije drugih izhodnih snovi, ki so uporabljene za modifikacijo makromolekule in niso vezane ali niso v celoti vezane, ali makromolekule, ki ni v celoti vezana.
Therefore the other starting substances as well as the macromolecules used in the manufacture of modified macromolecules should be risk assessed and authorised before their use in the manufacture of plastic materials and articles.
Zato je treba oceniti tveganje zaradi drugih izhodnih snovi in makromolekul, ki se uporabljajo pri proizvodnji modificiranih makromolekul, ter jih odobriti, preden se uporabijo za proizvodnjo polimernih materialov in izdelkov.
Plastics can also be made by micro-organisms that create macromolecular structures out of starting substances by fermentation processes.
Polimerni materiali so lahko sestavljeni tudi iz mikroorganizmov, ki v procesu fermentacije iz izhodnih snovi tvorijo makromolekularne strukture.
The macromolecule is then either released to a medium or extracted.
Makromolekula se nato sprosti v medij ali se ekstrahira.
Potential health risk may occur from the migration of non- or incompletely reacted starting substances, intermediates or by-products of the fermentation process.
Tveganje za zdravje se lahko pojavi zaradi migracije izhodnih snovi, ki niso vezane ali niso v celoti vezane, vmesnih spojin ali stranskih produktov pri procesu fermentacije.
In this case the final product should be risk assessed and authorised before its use in the manufacture of plastic materials and articles.
V tem primeru je treba za končni produkt opraviti oceno tveganja in ga odobriti, preden se uporabi za proizvodnjo polimernih materialov in izdelkov.
Directive 2002/72/EC contains different lists for monomers or other starting substances and for additives authorised for the manufacture of plastic materials and articles.
Direktiva 2002/72/ES vključuje različne sezname za monomere ali druge izhodne snovi in za aditive, odobrene za proizvodnjo polimernih materialov in izdelkov.
For monomers, other starting substances and additives the Union list is now complete, this means that only substances authorised at EU level may be used.
Za monomere, druge izhodne snovi in aditive je seznam Unije zdaj izčrpen, kar pomeni, da se lahko uporabljajo le snovi, odobrene na ravni EU.
Therefore a separation of monomers or other starting substances and of additives in separate lists due to their authorisation status is no longer necessary.
Zato monomerov ali drugih izhodnih snovi in aditivov ni treba več ločevati v različne sezname zaradi njihovega stanja odobritve.
As certain substances can be used both as monomer or other starting substances and as additive for reasons of clarity they should be published in one list of authorised substances indicating the authorised function.
Ker se lahko nekatere snovi uporabljajo kot monomer ali druge izhodne snovi in kot aditivi, jih je treba zaradi jasnosti objaviti na enem seznamu odobrenih snovi, pri čemer se navede odobrena funkcija.
Polymers can not only be used as main structural component of plastics but also as additives achieving defined technological effects in the plastic.
Polimeri se ne uporabljajo le kot glavna strukturna komponenta polimernih materialov, ampak tudi kot aditivi za doseganje opredeljenih tehnoloških učinkov pri polimernih materialih.
If such a polymeric additive is identical to a polymer that can form the main structural component of a plastic material the risk from polymeric additive can be regarded as evaluated if the monomers have already been evaluated and authorised.
Če je tak polimerni aditiv enak polimeru, ki lahko tvori glavno strukturno komponento polimernega materiala, je mogoče tveganje zaradi polimernega aditiva šteti za ocenjeno, če so bili monomeri že ocenjeni in odobreni.
In such a case it should not be necessary to authorise the polymeric additive but it could be used on the basis of the authorisation of its monomers and other starting substances.
V takem primeru ni treba odobriti polimernega aditiva, ampak se lahko uporablja na podlagi odobritve njegovih monomerov in drugih izhodnih snovi.
If such a polymeric additive is not identical to a polymer that can form the main structural component of a plastic material then the risk of the polymeric additive can not be regarded as evaluated by evaluation of the monomers.
Če tak polimerni aditiv ni enak polimeru, ki lahko tvori glavno strukturno komponento polimernega materiala, ni mogoče šteti, da je bilo tveganje zaradi polimernega aditiva ocenjeno na podlagi ocene monomerov.
In such a case the polymeric additive should be risk assessed as regards its low molecular weight fraction below 1000 Da and authorised before its use in the manufacture of plastic materials and articles.
V takem primeru je treba oceniti tveganje zaradi polimernega aditiva glede njegove frakcije z nizko molsko maso, nižjo od 1000 Da, in ga odobriti, preden se uporabi za proizvodnjo polimernih materialov in izdelkov.
In the past no clear differentiation has been made between additives that have a function in the final polymer and polymer production aids (PPA) that only exhibit a function in the manufacturing process and are not intended to be present in the final article.
V preteklosti se ni jasno razlikovalo med aditivi, ki imajo funkcijo v končnem polimeru, in pomožnimi sredstvi za polimerizacijo, ki imajo funkcijo le v proizvodnem procesu in niso namenjena vezavi v končni izdelek.
Some substances acting as PPA had already been included in the incomplete list of additives in the past.
Nekatere snovi, ki delujejo kot pomožna sredstva za polimerizacijo, so bile v preteklosti že vključene na neizčrpen seznam aditivov.
These PPA should remain in the Union list of authorised substances.
Ta pomožna sredstva je treba ohraniti na seznamu odobrenih snovi Unije.
However, it should be made clear that the use of other PPA will remain possible, subject to national law.
Vendar je treba pojasniti, da bo uporaba drugih pomožnih sredstev za polimerizacijo na podlagi nacionalne zakonodaje še naprej mogoča.
The Union list contains substances authorised to be used in the manufacture of plastics.
Seznam Unije vključuje snovi, odobrene za uporabo pri proizvodnji polimernih materialov.
Substances such as acids, alcohols and phenols can also occur in form of salts.
Snovi, kot so kisline, alkoholi in fenoli, so lahko tudi v obliki soli.
As the salts usually are transformed in the stomach to acid, alcohol or phenol the use of salts with cations that have undergone a safety evaluation should in principle be authorised together with the acid, alcohol or phenol.
Ker se soli v želodcu običajno pretvorijo v kislino, alkohol ali fenol, bi bilo treba uporabo soli s kationi, katerih varnost je bila ocenjena, načeloma odobriti hkrati s kislino, alkoholom ali fenolom.
In certain cases, where the safety assessment indicates concerns on the use of the free acids, only the salts should be authorised by indicating in the list the name as ‘… acid(s), salts’.
V nekaterih primerih, ko ocena varnosti povzroči dvome glede uporabe prostih kislin, je treba odobriti le soli, pri čemer je treba na seznamu ime navesti kot „kislina(-e), soli“.
Substances used in the manufacture of plastic materials or articles may contain impurities originating from their manufacturing or extraction process.
Snovi, ki se uporabljajo pri proizvodnji polimernih materialov ali izdelkov, lahko vsebujejo nečistoče, ki nastanejo pri procesu proizvodnje ali ekstrakcije.
These impurities are non-intentionally added together with the substance in the manufacture of the plastic material (non-intentionally added substance – NIAS).
Te nečistoče se pri proizvodnji polimernega materiala nenamerno dodajo snovi (nenamerno dodana snov).
As far as they are relevant for the risk assessment the main impurities of a substance should be considered and if necessary be included in the specifications of a substance.
Če so pomembne za oceno tveganja, je treba obravnavati glavne nečistoče v snovi in jih po potrebi vključiti v specifikacije snovi.
However it is not possible to list and consider all impurities in the authorisation.
Vendar ni mogoče, da bi pri odobritvi navedli in upoštevali vse nečistoče.
Therefore they may be present in the material or article but not included in the Union list.
Zato so lahko v materialu ali izdelku, tudi če niso vključene na seznam Unije.
In the manufacture of polymers substances are used to initiate the polymerisation reaction such as catalysts and to control the polymerisation reaction such as chain transfer, chain extending or chain stop reagents.
Pri proizvodnji polimerov se uporabljajo snovi za sprožitev polimerizacijske reakcije, kot so katalizatorji, in snovi za nadzor polimerizacijske reakcije, kot so reagenti za prenos verige, podaljševanje verige ali ustavitev verige.
These aids to polymerisation are used in minute amounts and are not intended to remain in the final polymer.
Te snovi za polimerizacijo se uporabljajo v zelo majhnih količinah in naj jih ne bi bilo v končnem polimeru.
Therefore they should at this point of time not be subject to the authorisation procedure at EU level.
Zato jih na tej točki ni treba vključiti v postopek odobritve na ravni EU.
Any potential health risk in the final material or article arising from their use should be assessed by the manufacturer in accordance with internationally recognised scientific principles on risk assessment.
Morebitno tveganje za zdravje v zvezi s končnim materialom ali izdelkom, ki izhaja iz njihove uporabe, mora proizvajalec oceniti v skladu z mednarodno priznanimi znanstvenimi načeli za oceno tveganja.
During the manufacture and use of plastic materials and articles reaction and degradation products can be formed.
Med proizvodnjo in uporabo polimernih materialov in izdelkov lahko nastanejo reakcijski in degradacijski produkti.
These reaction and degradation products are non-intentionally present in the plastic material (NIAS).
Ti reakcijski in degradacijski produkti so nenamerno prisotni v polimernem materialu.
As far as they are relevant for the risk assessment the main reaction and degradation products of the intended application of a substance should be considered and included in the restrictions of the substance.
Če so pomembni za oceno tveganja, je treba glavne reakcijske in degradacijske produkte pri predvideni uporabi snovi upoštevati in vključiti v omejitve glede snovi.
However it is not possible to list and consider all reaction and degradation products in the authorisation.
Vendar ni mogoče, da bi pri odobritvi navedli in upoštevali vse reakcijske in degradacijske produkte.
Therefore they should not be listed as single entries in the Union list.
Zato jih na seznamu Unije ni treba navesti kot ločene vnose.
Any potential health risk in the final material or article arising from reaction and degradation products should be assessed by the manufacturer in accordance with internationally recognised scientific principles on risk assessment.
Morebitno tveganje za zdravje v zvezi s končnim materialom ali izdelkom, ki izhaja iz reakcijskih in degradacijskih produktov, mora proizvajalec oceniti v skladu z mednarodno priznanimi znanstvenimi načeli za oceno tveganja.
Prior to the establishment of the Union list of additives, other additives than those authorised at EU level could be used in the manufacture of plastics.
Pred določitvijo seznama aditivov Unije je bilo mogoče pri proizvodnji polimernih materialov uporabljati druge aditive kot tiste, ki so odobreni na ravni EU.
For certain additives on the provisional list a decision on their authorisation at EU level has not yet been taken.
Glede nekaterih aditivov na začasnem seznamu še ni bila sprejeta odločitev o njihovi odobritvi na ravni EU.
For those additives, it should be possible to continue to be used in accordance with national law until their evaluation is completed and a decision is taken on their inclusion in the Union list.
Treba je omogočiti nadaljnjo uporabo teh aditivov na podlagi nacionalne zakonodaje, dokler se ne dokonča njihova ocena in se sprejme odločitev o njihovi vključitvi na seznam Unije.
When an additive included in the provisional list is inserted in the Union list or when it is decided not to include it in the Union list, that additive should be removed from the provisional list of additives.
Če se aditiv, ki je vključen na začasni seznam, vključi na seznam Unije ali se sklene, da se aditiv ne vključi na seznam Unije, je treba navedeni aditiv odstraniti z začasnega seznama aditivov.
New technologies engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles.
Z novo tehnologijo se ustvarjajo snovi z zmanjšano velikostjo delcev, na primer nanodelci, s kemičnimi in fizikalnimi lastnostmi, ki so znatno drugačne kot pri istih snoveh z večjimi delci.
These different properties may lead to different toxicological properties and therefore these substances should be assessed on a case-by-case basis by the Authority as regards their risk until more information is known about such new technology.
Te drugačne lastnosti lahko povzročijo drugačne toksikološke lastnosti, zato mora Agencija za te snovi oceniti tveganje za vsak primer posebej, dokler o tej novi tehnologiji ne bo na voljo več informacij.
Therefore it should be made clear that authorisations which are based on the risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles.
Zato je treba jasno določiti, da odobritve, ki temeljijo na oceni tveganja za snov z običajno velikostjo delcev, ne vključujejo proizvedenih nanodelcev.
Based on the risk assessment the authorisation should if necessary set out specific migration limits to ensure the safety of the final material or article.
Na podlagi ocene tveganja je treba v dovoljenju po potrebi določiti mejne vrednosti specifične migracije za zagotovitev varnosti končnega materiala ali izdelka.
If an additive that is authorised for the manufacture of plastic materials and articles is at the same time authorised as food additive or flavouring substance it should be ensured that the release of the substance does not change the composition of the food in an unacceptable way.
Če je aditiv, ki je odobren za proizvodnjo polimernih materialov in izdelkov, hkrati odobren tudi kot živilski aditiv ali aromatična snov, je treba zagotoviti, da izločanje te snovi nesprejemljivo ne spremeni sestave živila.
Therefore the release of such a dual use additive or flavouring should not exhibit a technological function on the food unless such a function is intended and the food contact material complies with the requirements on active food contact materials set out in Regulation (EC) No 1935/2004 and Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food [4].
Zato izločanje takega aditiva ali arome z dvojno uporabo ne sme imeti tehnološke funkcije v živilu, razen če je taka funkcija predvidena in material za stik z živili izpolnjuje zahteve o aktivnih materialih in izdelkih za stik z živili iz Uredbe (ES) št. 1935/2004 in Uredbe Komisije št. 450/2009 z dne 29. maja 2009 o aktivnih in inteligentnih materialih in izdelkih, namenjenih za stik z živili [4].
The requirements of Regulations (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [5] or (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC [6] should be respected where applicable.
Zahteve iz Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta dne 16. decembra 2008 o aditivih za živila [5] ali Uredbe (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih ter spremembi Uredbe Sveta (EGS) št. 1601/91, uredb (ES) št. 2232/96 in (ES) št. 110/2008 ter Direktive 2000/13/ES [6] je treba izpolniti, kadar je to ustrezno.
According to Article 3(1)(b) of Regulation (EC) No 1935/2004 the release of substances from food contact materials and articles should not bring about unacceptable changes in the composition of the food.
V skladu s členom 3(1)(b) Uredbe (ES) št. 1935/2004 prehajanje snovi iz materialov in izdelkov, namenjenih za stik z živili, ne sme povzročiti nesprejemljive spremembe v sestavi živil.
According to good manufacturing practice it is feasible to manufacture plastic materials in such a way that they are not releasing more than 10 mg of substances per 1 dm2 of surface area of the plastic material.
Glede na dobro proizvodno prakso je mogoče polimerne materiale proizvajati tako, da ne izločijo več kot 10 miligramov snovi na 1 dm2 površine polimernega materiala.
If the risk assessment of an individual substance is not indicating a lower level, this level should be set as a generic limit for the inertness of a plastic material, the overall migration limit.
Če se pri oceni tveganja zaradi posamezne snovi ne ugotovi nižja raven, je treba to raven določiti kot splošno mejno vrednost za inertnost polimernega materiala, tj. mejno vrednost celotne migracije.
In order to achieve comparable results in the verification of compliance with the overall migration limit, testing should be performed under standardised test conditions including testing time, temperature and test medium (food simulant) representing worst foreseeable conditions of use of the plastic material or article.
Za doseganje primerljivih rezultatov pri preverjanju skladnosti z mejno vrednostjo celotne migracije je treba preskuse opraviti v standardiziranih preskusnih okoliščinah, vključno s preskusnim časom, temperaturo in preskusnim medijem (modelna raztopina za živila), ki so najslabše predvidljive okoliščine uporabe polimernega materiala ali izdelka.
The overall migration limit of 10 mg per 1 dm2 results for a cubic packaging containing 1kg of food to a migration of 60 mg per kg food.
Pri mejni vrednosti celotne migracije 10 miligramov na 1 dm2 se pri kockasti embalaži, ki vsebuje 1 kilogram živila, pojavi migracija 60 miligramov na kilogram živila.
For small packaging where the surface to volume ratio is higher the resulting migration into food is higher.
Pri manjši embalaži, ko je razmerje med površino in prostornino večje, je migracija v živilo posledično višja.