natgillin/translations-raw huggingface dataset:
For infants and small children which have a higher consumption of food per kilogram bodyweight than adults and do not yet have a diversified nutrition, special provisions should be set in order to limit the intake of substances migrating from food contact materials.
Za dojenčke in majhne otroke, pri katerih je poraba živila na kilogram telesne teže večja kot pri odraslih, hkrati pa njihova prehrana še ni raznovrstna, je treba določiti posebne predpise za omejitev vnosa snovi, ki se izločajo iz materialov za stik z živili.
In order to allow also for small volume packaging the same protection as for high volume packaging, the overall migration limit for food contact materials that are dedicated for packaging foods for infants and small children should be linked to the limit in food and not to the surface area of the packaging.
Da bi se tudi za embalažo z majhno prostornino zagotovila enaka zaščita kot za embalažo z večjo prostornino, je treba mejno vrednost celotne migracije za materiale za stik z živili, ki so namenjeni pakiranju živil za dojenčke in majhne otroke, povezati z mejno vrednostjo za živilo in ne s površino embalaže.
In recent years plastic food contact materials are being developed that do not only consist of one plastic but combine up to 15 different plastic layers to attain optimum functionality and protection of the food, while reducing packaging waste.
V zadnjih letih se razvijajo polimerni materiali za stik z živili, ki niso sestavljeni le iz enega polimernega materiala, ampak združujejo do 15 različnih plasti iz polimernih materialov za doseganje optimalne funkcionalnosti in zaščite živil ter hkrati zmanjšanje količine odpadne embalaže.
Behind a functional barrier, non-authorised substances may be used, provided they fulfil certain criteria and their migration remains below a given detection limit.
Za funkcionalno pregrado se lahko uporabijo neodobrene snovi, če izpolnjujejo nekatera merila in ostane njihova migracija pod dano mejno vrednostjo zaznavnosti.
Taking into account foods for infants and other particularly susceptible persons, as well as the large analytical tolerance of the migration analysis, a maximum level of 0,01 mg/kg in food should be established for the migration of a non-authorised substance through a functional barrier.
Ob upoštevanju živil za dojenčke in druge posebno občutljive osebe ter velike merilne negotovosti pri analizi migracije je treba pri živilih za migracijo neodobrene snovi skozi funkcionalno pregrado določiti mejno vrednost 0,01 mg/kg.
Substances that are mutagenic, carcinogenic or toxic to reproduction should not be used in food contact materials or articles without previous authorisation and should therefore not be covered by the functional barrier concept.
Snovi, ki so mutagene, rakotvorne ali strupene za razmnoževanje, se v materialih ali izdelkih, namenjenih za stik z živili, brez predhodne odobritve ne smejo uporabljati, zato niso vključene v koncept funkcionalne pregrade.
New technologies that engineer substances in particle size that exhibit chemical and physical properties that significantly differ from those at a larger scale, for example, nanoparticles, should be assessed on a case-by-case basis as regards their risk until more information is known about such new technology.
Nove tehnologije, s katerimi se ustvarjajo snovi z zmanjšano velikostjo delcev, na primer nanodelcev, s kemičnimi in fizikalnimi lastnostmi, ki so znatno drugačne kot pri istih snoveh z večjimi delci, bi bilo treba oceniti za vsak primer posebej, kar zadeva njihovo tveganje, dokler o tej novi tehnologiji ne bo na voljo več informacij.
Therefore, they should not be covered by the functional barrier concept.
Koncept funkcionalne pregrade teh snovi zato ne bi smel zajeti.
In recent years food contact materials and articles are being developed that consist of a combination of several materials to achieve optimum functionality and protection of the food while reducing packaging waste.
V zadnjih letih se razvijajo materiali in izdelki za stik z živili, ki so sestavljeni iz kombinacije več materialov za doseganje optimalne funkcionalnosti in zaščite živil ter hkratno zmanjšanje količine odpadne embalaže.
In these multi-material multi-layer materials and articles plastic layers should comply with the same compositional requirements as plastic layers which are not combined with other materials.
Pri teh večmaterialnih večplastnih materialih in izdelkih morajo plasti iz polimernih materialov izpolnjevati enake zahteve glede sestave kot plasti iz polimernih materialov, ki se ne kombinirajo z drugimi materiali.
For plastic layers in a multi-material multi-layer which are separated from the food by a functional barrier the functional barrier concept should apply.
Za plasti iz polimernih materialov v večmaterialnih večplastnih materialih ali izdelkih, ki so s funkcionalno pregrado ločene od živila, je treba uporabiti koncept funkcionalne pregrade.
As other materials are combined with the plastic layers and for these other materials specific measures are not yet adopted at EU level it is not yet possible to set out requirements for the final multi-material multi-layer materials and articles.
Ker se s plastmi iz polimernih materialov kombinirajo drugi materiali, za katere na ravni EU še niso bili sprejeti posebni ukrepi, še ni mogoče določiti zahtev za končne večmaterialne večplastne materiale in izdelke.
Therefore specific migration limits and the overall migration limit should not be applicable except for vinyl chloride monomer for which such a restriction is already in place.
Zato se lahko mejne vrednosti specifične migracije in mejna vrednost celotne migracije uporabljajo le za monomer vinilklorid, za katerega taka omejitev že velja.
In the absence of a specific measure at EU level covering the whole multi-material multi-layer material or article Member States may maintain or adopt national provisions for these materials and articles provided they comply with the rules of the Treaty.
Ker na ravni EU ni posebnega ukrepa, ki bi pokrival vse večmaterialne večplastne materiale ali izdelke, lahko države članice za te materiale in izdelke ohranijo ali sprejmejo nacionalne določbe, če so te v skladu s pravili iz Pogodbe.
Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them.
Člen 16(1) Uredbe (ES) št. 1935/2004 določa, da se materialom in izdelkom, ki jih zajemajo posebni ukrepi, priloži pisna izjava o skladnosti, da so skladni s predpisi, ki se zanje uporabljajo.
To strengthen the coordination and responsibility of the suppliers at each stage of manufacture, including that of the starting substances, the responsible persons should document the compliance with the relevant rules in a declaration of compliance which is made available to their customers.
Za večjo usklajenost in odgovornost dobaviteljev na vsaki stopnji proizvodnje, vključno s proizvodnjo izhodnih snovi, morajo odgovorne osebe v izjavi o skladnosti, ki jo dajo na voljo strankam, navesti skladnost z ustreznimi pravili.
Coatings, printing inks and adhesives are not yet covered by a specific EU legislation and therefore not subject to the requirement of a declaration of compliance.
Premazi, barve za tiskanje in lepila še niso urejeni s posebno zakonodajo EU, zato zanje zahteva glede izjave o skladnosti ne velja.
However, for coatings, printing inks and adhesives to be used in plastic materials and articles adequate information should be provided to the manufacturer of the final plastic article that would enable him to ensure compliance for substances for which migration limits have been established in this Regulation.
Vendar mora proizvajalec končnega polimernega izdelka predložiti ustrezne informacije za premaze, barve za tiskanje in lepila, ki se uporabljajo v polimernih materialih in izdelkih, da lahko zagotovi skladnost snovi, za katere so v tej uredbi določene mejne vrednosti migracije.
Article 17(1) of 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 [7] requires the food business operator to verify that foods are compliant with the rules applicable to them.
Člen 17(1) Uredbe (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 [7], določa, da morajo nosilci živilske dejavnosti preveriti, ali so živila v skladu s pravili, ki veljajo zanje.
To this end and subject to the requirement of confidentiality, food business operators should be given access to the relevant information to enable them to ensure that the migration from the materials and articles to food complies with the specifications and restrictions laid down in food legislation.
V ta namen mora nosilec živilske dejavnosti ob upoštevanju načela zaupnosti imeti dostop do ustreznih informacij, da lahko zagotovi, da je migracija iz materialov in izdelkov v živilo v skladu z zahtevami in omejitvami iz živilske zakonodaje.
At each stage of manufacture, supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities.
Pristojnim organom mora biti na vsaki stopnji proizvodnje na voljo spremna dokumentacija, ki utemeljuje podatke v izjavi o skladnosti.
Such demonstration of compliance may be based on migration testing.
Tak dokaz skladnosti lahko temelji na migracijskih preskusih.
As migration testing is complex, costly and time consuming it should be admissible that compliance can be demonstrated also by calculations, including modelling, other analysis, and scientific evidence or reasoning if these render results which are at least as severe as the migration testing.
Ker so migracijski preskusi zahtevni, dragi in zamudni, je treba dovoliti, da se skladnost dokazuje tudi z izračuni, vključno z modeliranjem, drugimi analizami in znanstvenimi dokazi ali utemeljitvami, če se s tem pridobijo rezultati, ki so vsaj tako natančni kot pri migracijskih preskusih.
Test results should be regarded as valid as long as formulations and processing conditions remain constant as part of a quality assurance system.
Rezultate preskusa je treba šteti za veljavne, če formulacije in razmere obdelave ostanejo stalne kot del sistema za zagotavljanje kakovosti.
When testing articles not yet in contact with food, for certain articles, such as films or lids, it is often not feasible to determine the surface area that is in contact with a defined volume of food.
Pri preskušanju izdelkov, ki še niso v stiku z živili, za nekatere izdelke, kot so filmi ali pokrovi, pogosto ni mogoče opredeliti površine, ki je v stiku z zadevno količino živila.
For these articles specific rules should be set out for verification of compliance.
Za te izdelke je treba za preverjanje skladnosti določiti posebna pravila.
The setting of migration limits takes into account a conventional assumption that 1kg of food is consumed daily by a person of 60 kg bodyweight and that the food is packaged in a cubic container of 6 dm2 surface area releasing the substance.
Pri določanju mejnih vrednosti migracije se upošteva običajna domneva, da oseba s 60 kilogrami telesne mase na dan zaužije en kilogram hrane, pri čemer je hrana pakirana v kockasti posodi s površino 6 dm2, ki izloča snov.
For very small and very large containers the real surface area to volume of packaged food is varying a lot from the conventional assumption.
Za zelo majhne in zelo velike posode se razmerje med dejansko površino in količino pakiranega živila zelo razlikuje od običajne domneve.
Therefore, their surface area should be normalised before comparing testing results with migration limits.
Zato je treba njihovo površino standardizirati pred primerjavo preskusnih rezultatov z mejnimi vrednostmi migracije.
These rules should be reviewed when new data on food packaging uses become available.
Ta pravila je treba pregledati, ko bodo na voljo novi podatki o uporabi embalaže za živila.
It should be ensured by the manufacturer that materials and articles not yet in contact with food will respect these limits when brought into contact with food under the worst foreseeable contact conditions.
Proizvajalec mora zagotoviti, da materiali in izdelki, ki še niso v stiku z živili, ne presegajo teh mejnih vrednosti, ko pridejo v stik z živili v najslabših predvidljivih okoliščinah stika.
Therefore compliance of materials and articles not yet in contact with food should be assessed and the rules for this testing should be set out.
Zato je treba oceniti skladnost materialov in izdelkov, ki še niso v stiku z živili, in določiti pravila za te preskuse.
Food is a complex matrix and therefore the analysis of migrating substances in food may pose analytical difficulties.
Živila so zapletena matrica, zato se lahko pri analizi migracijskih snovi v živilih pojavijo težave.
Therefore test media should be assigned that simulate the transfer of substances from the plastic material into food.
Zato je treba določiti preskusne medije, ki posnemajo prehajanje snovi iz polimernega materiala v živilo.
They should represent the major physico-chemical properties exhibited by food.
Imeti morajo glavne fizikalno-kemijske lastnosti živila.
When using food simulants standard testing time and temperature should reproduce, as far as possible, the migration which may occur from the article into the food.
Pri uporabi modelnih raztopin za živila je treba zagotoviti, da standardna preskusna čas in temperatura čim bolj posnemata morebitno migracijo iz izdelka v živilo.
For determining the appropriate food simulant for certain foods the chemical composition and the physical properties of the food should be taken into account.
Za določitev ustrezne modelne raztopine za posamezno živilo je treba upoštevati kemijsko sestavo in fizikalne lastnosti živila.
Research results are available for certain representative foods comparing migration into food with migration into food simulants.
Za nekatera reprezentativna živila so na voljo rezultati raziskav o primerjavi migracije v živilo z migracijo v modelne raztopine živila.
On the basis of the results, food simulants should be assigned.
Na podlagi rezultatov je treba dodeliti modelne raztopine.
In particular, for fat containing foods the result obtained with food simulant may in certain cases significantly overestimate migration into food.
Zlasti pri živilih, ki vsebujejo maščobe, je lahko rezultat glede migracije v živilo, pridobljen z modelno raztopino, v nekaterih primerih previsok.
In these cases it should be foreseen that the result in food simulant is corrected by a reduction factor.
V teh primerih je treba predvideti prilagoditev rezultata pri modelni raztopini z redukcijskim faktorjem.
The exposure to substances migrating from food contact materials was based on the conventional assumption that a person consumes daily 1 kg of food.
Izpostavljenost snovem, ki se izločajo iz materialov, namenjenih za stik z živili, je temeljila na običajni domnevi, da oseba dnevno zaužije en kilogram hrane.
However, a person ingests at most 200 g of fat on a daily basis.
Vendar oseba na dan zaužije največ 200 gramov maščobe.
For lipophilic substances that only migrate into fat this should be taken into consideration.
To je treba upoštevati pri lipofilnih snoveh, ki se izločajo le v maščobo.
Therefore a correction of the specific migration by a correction factor applicable to lipophilic substances in accordance with the opinion of the Scientific Committee on Food (SCF) [8] and the opinion of the Authority [9] should be foreseen.
Zato je treba predvideti popravek specifične migracije s korekcijskim faktorjem, ki se uporablja za lipofilne snovi, v skladu z mnenjem Znanstvenega odbora za prehrano [8] in mnenjem Agencije [9].
Official control should establish testing strategies which allow the enforcement authorities to perform controls efficiently making best use of available resources.
Pri uradnem nadzoru je treba vzpostaviti preskusne strategije, ki pristojnim organom omogočajo učinkovito izvajanje nadzora z najboljšo uporabo razpoložljivih sredstev.
Therefore it should be admissible to use screening methods for checking compliance under certain conditions.
Zato je treba v nekaterih okoliščinah dovoliti uporabo presejalnih metod za preverjanje skladnosti.
Non-compliance of a material or article should be confirmed by a verification method.
Neskladnost materiala ali izdelka je treba potrditi z metodo preverjanja.
Basic rules on migration testing should be set out in this Regulation.
V tej uredbi je treba določiti temeljna pravila za migracijske preskuse.
As migration testing is a very complex issue, these basic rules can, however, not cover all foreseeable cases and details necessary for performing the testing.
Ker je preskušanje migracije zelo zahtevna naloga, ta temeljna pravila seveda ne morejo vključevati vseh predvidljivih primerov in podrobnosti, potrebnih za izvedbo preskusov.
Therefore a EU guidance document should be established, dealing with more detailed aspects of the implementation of the basic migration testing rules.
Zato je treba pripraviti dokument EU s smernicami, v katerih bodo obravnavani podrobnejši vidiki izvajanja temeljnih pravil za migracijske preskuse.
The updated rules on food simulants and migration testing provided by this Regulation will supersede those in Directive 78/142/EEC and the Annex to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs [10].
Posodobljena pravila o modelnih raztopinah za živila in migracijske preskuse iz te uredbe bodo nadomestila pravila iz Direktive 78/142/EGS in Priloge k Direktivi Sveta 82/711/EGS z dne 18. oktobra 1982 o določitvi temeljnih pravil za preskušanje migracije sestavin polimernih materialov in izdelkov, namenjenih za stik z živili [10].
Substances present in the plastic but not listed in Annex I to this Regulation have not necessarily been risk assessed as they had not been subject to an authorisation procedure.
Za snovi, ki so prisotne v polimernih materialih, vendar niso navedene v Prilogi I k tej uredbi, se tveganje morda ni ocenilo, saj niso bile vključene v postopek odobritve.
Compliance with Article 3 of Regulation (EC) No 1935/2004 for these substances should be assessed by the relevant business operator in accordance with internationally recognised scientific principles taking into account exposure from food contact materials and other sources.
Skladnost teh snovi s členom 3 Uredbe (ES) št. 1935/2004 mora oceniti ustrezni nosilec dejavnosti v skladu z mednarodno priznanimi znanstvenimi načeli ob upoštevanju izpostavljenosti zaradi materialov, namenjenih za stik z živili, in drugih virov.
Recently additional monomers, other starting substances and additives have received a favourable scientific evaluation by the Authority and should now be added to the Union list.
Agencija je pred kratkim pozitivno znanstveno ocenila dodatne monomere, druge izhodne snovi in aditive, ki jih je zdaj treba vključiti na seznam Unije.
As new substances are added to the Union list the Regulation should apply as soon as possible to allow for manufacturers to adapt to technical progress and allow for innovation.
Ker se na seznam Unije dodajajo nove snovi, je treba Uredbo začeti uporabljati čim prej, da se lahko proizvajalci prilagodijo tehnološkemu napredku in se omogočijo inovacije.
Certain migration testing rules should be updated in view of new scientific knowledge.
Glede na nova znanstvena spoznanja je treba posodobiti nekatera pravila za migracijske preskuse.
Enforcement authorities and industry need to adapt their current testing regime to these updated rules.
Pristojni organi in industrija morajo svoje obstoječe sisteme za preskuse prilagoditi tem posodobljenim pravilom.
To allow for this adaptation it seems appropriate that the updated rules only apply 2 years after the adoption of the Regulation.
Zdi se, da je za to prilagoditev primerno, da posodobljena pravila začnejo veljati šele dve leti po sprejetju Uredbe.
Business operators are currently basing their declaration of compliance on supporting documentation following the requirements set out in Directive 2002/72/EC.
Nosilci dejavnosti svojo izjavo o skladnosti zdaj utemeljujejo s spremno dokumentacijo na podlagi zahtev iz Direktive 2002/72/ES.
Declaration of compliance need, in principle, only to be updated when substantial changes in the production bring about changes in the migration or when new scientific data are available.
Izjavo o skladnosti je treba načeloma posodobiti le, če znatne spremembe v proizvodnji povzročijo spremembe v migraciji ali če so na voljo novi znanstveni podatki.
In order to limit the burden to business operators, materials which have been lawfully placed on the market based on the requirements set out in Directive 2002/72/EC should be able to be placed on the market with a declaration of compliance based on supporting documentation in accordance with Directive 2002/72/EC until 5 years after the adoption of the Regulation.
Za manjšo obremenitev nosilcev dejavnosti je treba omogočiti, da se materiali, ki so bili zakonito dani v promet v skladu z zahtevami iz Direktive 2002/72/ES, dajejo v promet z izjavo o skladnosti, ki temelji na spremni dokumentaciji v skladu z Direktivo 2002/72/ES, še pet let po sprejetju Uredbe.
Analytical methods for testing migration and residual content of vinyl chloride monomer as described in Commission Directives 80/766/EEC of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs [11] and 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs [12] are outdated.
Analizne metode za preskušanje migracije in količine preostanka monomera vinilklorida, kot so opisane v direktivah Komisije 80/766/EGS z dne 8. julija 1980 o določitvi analiznih metod Skupnosti za uradni nadzor vsebnosti monomera vinilklorida v materialih in izdelkih, namenjenih za stik z živili [11], in 81/432/EGS dne 29. aprila 1981 o določitvi analiznih metod Skupnosti za uradni nadzor vinilklorida, ki prehaja iz materialov in izdelkov v živila [12], so zastarele.
Analytical methods should comply with the criteria set out in Article 11 of Regulation (EC) No 882/2004 [13] of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
Analizne metode morajo izpolnjevati merila iz člena 11 Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta [13] 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.
Therefore Directives 80/766/EEC and 81/432/EEC should be repealed.
Zato je treba direktivi 80/766/EGS in 81/432/EGS razveljaviti.
This Regulation is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004.
Ta uredba je posebni ukrep v smislu člena 5 Uredbe (ES) št. 1935/2004.
This Regulation establishes specific requirements for the manufacture and marketing of plastic materials and articles:
Ta uredba določa posebne zahteve za proizvodnjo in trženje polimernih materialov in izdelkov:
intended to come into contact with food; or
ki so namenjeni za stik z živili ali
already in contact with food; or
so že v stiku z živili ali
which can reasonably be expected to come into contact with food.
za katere je mogoče razumno pričakovati, da bodo v stiku z živili.
This Regulation shall apply to materials and articles which are placed on the EU market and fall under the following categories:
Ta uredba se uporablja za materiale in izdelke, ki so dani v promet v EU in spadajo v naslednje kategorije: