natgillin/translations-raw huggingface dataset:
The final plastic multi-layer material or article shall comply with the specific migration limits set out in Article 11 and the overall migration limit set out in Article 12 of this Regulation.
Končni polimerni večplastni material ali izdelek je v skladu z mejnimi vrednostmi specifične migracije iz člena 11 in mejno vrednostjo celotne migracije iz člena 12 te uredbe.
Multi-material multi-layer materials and articles
Večmaterialni večplastni materiali in izdelki
In a multi-material multi-layer material or article, the composition of each plastic layer shall comply with this Regulation.
Pri večmaterialnem večplastnem materialu ali izdelku je sestava vsake plasti iz polimernih materialov v skladu s to uredbo.
By derogation from paragraph 1, in a multi-material multi-layer material or article a plastic layer which is not in direct contact with food and is separated from the food by a functional barrier, may be manufactured with substances not listed in the Union list or the provisional list.
Z odstopanjem od odstavka 1 se lahko pri večmaterialnem večplastnem materialu ali izdelku plast iz polimernih materialov, ki ni v neposrednem stiku z živilom in je od živila ločena s funkcionalno pregrado, proizvede iz snovi, ki niso navedene na seznamu Unije ali začasnem seznamu.
The substances not listed in the Union list or provisional list referred to in paragraph 2 shall not belong to either of the following categories:
Snovi, ki niso navedene na seznamu Unije ali začasnem seznamu iz odstavka 2, ne spadajo v nobeno od naslednjih kategorij:
substances classified as ‘mutagenic’, ‘carcinogenic’ or ‘toxic to reproduction’ in accordance with the criteria set out in sections 3.5, 3.6. and 3.7 of Annex I to Regulation (EC) No 1272/2008;
snovi, ki so opredeljene kot „mutagene“, „rakotvorne“ ali „strupene za razmnoževanje“ v skladu z merili iz oddelkov 3.5, 3.6. in 3.7 Priloge I k Uredbi (ES) št. 1272/2008;
By derogation from paragraph 1, Articles 11 and 12 of this Regulation do not apply to plastic layers in multi-material multi-layer materials and articles.
Z odstopanjem od odstavka 1 se člena 11 in 12 te uredbe ne uporabljata za plasti iz polimernih materialov v večmaterialnih večplastnih materialih in izdelkih.
The plastic layers in a multi-material multi-layer material or article shall always comply with the restrictions for vinyl chloride monomer laid down in Annex I to this Regulation.
Plasti iz polimernih materialov v večmaterialnem večplastnem materialu ali izdelku so vedno v skladu z omejitvami za monomer vinilklorid iz Priloge I k tej uredbi.
In a multi-material multi-layer material or article, specific and overall migration limits for plastic layers and for the final material or article may be established by national law.
Mejne vrednosti specifične in celotne migracije se lahko za plasti iz polimernih materialov ter za končni material ali izdelek pri večmaterialnem večplastnem materialu ali izdelku določijo z nacionalno zakonodajo.
At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004 shall be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles.
V fazah trženja, razen pri trgovini na drobno, se polimernim materialom in izdelkom, produktom iz vmesnih stopenj njihove proizvodnje ter snovem, namenjenim za proizvodnjo teh materialov in izdelkov, priloži pisna izjava v skladu s členom 16 Uredbe (ES) št. 1935/2004.
The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.
Pisno izjavo iz odstavka 1 izda nosilec dejavnosti in vključuje informacije iz Priloge VI.
The written declaration shall permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued.
Pisna izjava omogoča preprosto identifikacijo materialov, izdelkov ali produktov iz vmesnih stopenj proizvodnje ali snovi, za katere se izda.
It shall be renewed when substantial changes in the composition or production occur that bring about changes in the migration from the materials or articles or when new scientific data becomes available.
Obnovi se, kadar večje spremembe v sestavi ali proizvodnji povzročijo spremembe v migraciji iz materialov ali izdelkov ali kadar so na voljo novi znanstveni podatki.
Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request.
Nosilec dejavnosti na zahtevo nacionalnih pristojnih organov da na voljo ustrezno dokumentacijo, ki dokazuje, da so materiali in izdelki, produkti iz vmesnih stopenj njihove proizvodnje ter snovi, namenjene za proizvodnjo teh materialov in izdelkov, v skladu z zahtevami te uredbe.
That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance.
Ta dokumentacija vključuje razmere in rezultate preskusov, izračune, vključno z modeliranjem, druge analize ter dokaze o varnosti ali utemeljitve, ki dokazujejo skladnost.
Rules for experimental demonstration of compliance are set out in Chapter V.
Pravila za prikaz skladnosti s poskusi so določena v poglavju V.
COMPLIANCE
SKLADNOST
Expression of migration test results
Izražanje rezultatov migracijskega preskusa
To check the compliance, the specific migration values shall be expressed in mg/kg applying the real surface to volume ratio in actual or foreseen use.
Za preverjanje skladnosti se vrednosti specifične migracije izrazijo v mg/kg, pri čemer se uporabi razmerje med dejansko površino in prostornino pri dejanski ali predvideni uporabi.
By derogation from paragraph 1 for:
Od odstavka 1 odstopajo:
containers and other articles, containing or intended to contain, less than 500 millilitres or grams or more than 10 litres,
posode in drugi izdelki, ki vsebujejo ali so namenjeni za manj kot 500 mililitrov ali gramov oziroma več kot 10 litrov;
materials and articles for which, due to their form it is impracticable to estimate the relationship between the surface area of such materials or articles and the quantity of food in contact therewith,
materiali in izdelki, pri katerih zaradi njihove oblike ni mogoče oceniti razmerja med površino takih materialov ali izdelkov in količino živila, ki je v stiku z njimi;
sheets and films that are not yet in contact with food,
plošče in filmi, ki še niso v stiku z živili;
sheets and films containing less than 500 millilitres or grams or more than 10 litres,
plošče in filmi, ki vsebujejo manj kot 500 mililitrov ali gramov oziroma več kot 10 litrov,
the value of migration shall be expressed in mg/kg applying a surface to volume ratio of 6 dm2 per kg of food.
vrednost migracije se izrazi v mg/kg, pri čemer se uporabi razmerje med površino in prostornino 6 dm2 na kilogram živila.
This paragraph does not apply to plastic materials and articles intended to be brought into contact with or already in contact with food for infants and young children, as defined by Directives 2006/141/EC and 2006/125/EC.
Ta odstavek se ne uporablja za polimerne materiale in izdelke, ki so namenjeni za stik z živili za dojenčke in majhne otroke ali so že v stiku s takimi živili, kot so opredeljeni v direktivah 2006/141/ES in 2006/125/ES.
By derogation from paragraph 1, for caps, gaskets, stoppers and similar sealing articles the specific migration value shall be expressed in:
Z odstopanjem od odstavka 1 se za pokrovčke, tesnila, zamaške in podobne izdelke za zapiranje izrazi vrednost posebne migracije v:
mg/kg using the actual content of the container for which the closure is intended or in mg/dm2 applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2;
mg/kg z uporabo dejanske vsebine posode, za zapiranje katere je namenjeno, ali v mg/dm2 na podlagi celotne stične površine izdelka za zapiranje in zaprte posode, če je znana predvidena uporaba izdelka, ob upoštevanju določb iz odstavka 2;
mg/article if the intended use of the article is unknown.
mg/izdelek, če predvidena uporaba izdelka ni znana.
For caps, gaskets, stoppers and similar sealing articles the overall migration value shall be expressed in:
Za pokrovčke, tesnila, zamaške in podobne izdelke za zapiranje se vrednost celotne migracije izrazi v:
mg/dm2 applying the total contact surface of sealing article and sealed container if the intended use of the article is known;
mg/dm2 na podlagi celotne stične površine izdelka za zapiranje in zaprte posode, če je predvidena uporaba izdelka znana;
Rules for assessing compliance with migration limits
Pravila za ocenjevanje skladnosti z mejnimi vrednostmi migracije
For materials and articles already in contact with food verification of compliance with specific migration limits shall be carried out in accordance with the rules set out in Chapter 1 of Annex V.
Za materiale in izdelke, ki so že v stiku z živili, se preverjanje skladnosti z mejnimi vrednostmi specifične migracije izvede v skladu s pravili iz poglavja 1 Priloge V.
For materials and articles not yet in contact with food verification of compliance with specific migration limits shall be carried out in food or in food simulants set out in Annex III in accordance with the rules set out in Chapter 2, Section 2.1 of Annex V.
Za materiale in izdelke, ki še niso v stiku z živili, se preverjanje skladnosti z mejnimi vrednostmi specifične migracije izvede na živilih ali modelnih raztopinah iz Priloge III v skladu s pravili iz oddelka 2.1 poglavja 2 Priloge V.
For materials and articles not yet in contact with food screening of compliance with the specific migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 2, Section 2.2 of Annex V. If a material or article fails to comply with the migration limits in the screening approach a conclusion of non-compliance has to be confirmed by verification of compliance in accordance with paragraph 2.
Za materiale in izdelke, ki še niso v stiku z živili, se pregled skladnosti z mejno vrednostjo specifične migracije lahko izvede s presejalnimi pristopi v skladu s pravili iz oddelka 2.2 poglavja 2 Priloge V. Če material ali izdelek ni v skladu z mejnimi vrednostmi migracije v presejalnem pristopu, je treba ugotovitev o neskladnosti potrditi s preverjanjem skladnosti na podlagi odstavka 2.
For materials and articles not yet in contact with food verification of compliance with the overall migration limit shall be carried out in food simulants A, B, C, D1 and D2 as set out in Annex III in accordance with the rules set out in Chapter 3, Section 3.1 of Annex V.
Za materiale in izdelke, ki še niso v stiku z živili, se preverjanje skladnosti z mejno vrednostjo celotne migracije izvede na modelnih raztopinah A, B, C, D1 in D2 iz Priloge III v skladu s pravili iz oddelka 3.1 poglavja 3 Priloge V.
For materials and articles not yet in contact with food screening of compliance with the overall migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 3, Section 3.4 of Annex V. If a material or article fails to comply with the migration limit in the screening approach a conclusion of non-compliance has to be confirmed by verification of compliance in accordance with paragraph 4.
Za materiale in izdelke, ki še niso v stiku z živili, se pregled skladnosti z mejno vrednostjo celotne migracije lahko izvede s presejalnimi pristopi v skladu s pravili iz oddelka 3.4 poglavja 3 Priloge V. Če material ali izdelek ni v skladu z mejno vrednostjo migracije v presejalnem pristopu, je treba ugotovitev o neskladnosti potrditi s preverjanjem skladnosti na podlagi odstavka 4.
The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant.
Rezultati preskušanja specifične migracije, pridobljeni na živilih, imajo prednost pred rezultati, pridobljenimi z modelno raztopino.
The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches.
Rezultati preskušanja specifične migracije, pridobljeni z modelno raztopino, imajo prednost pred rezultati, pridobljenimi s presejalnimi pristopi.
Before comparing specific and overall migration test results with the migration limits the correction factors in Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.
Pred primerjavo rezultatov preskušanja specifične in celotne migracije z mejnimi vrednostmi migracije se uporabijo korekcijski faktorji iz poglavja 4 Priloge V v skladu s pravili iz navedenega poglavja.
Assessment of substances not included in the Union list
Ocenjevanje snovi, ki niso vključene na seznam Unije
Compliance with Article 3 of Regulation (EC) No 1935/2004 of substances referred to in Articles 6(1), 6(2), 6(4), 6(5) and 14(2) of this Regulation which are not covered by an inclusion in Annex I to this Regulation shall be assessed in accordance with internationally recognised scientific principles on risk assessment.
Za snovi iz člena 6(1), (2), (4) in (5) ter člena 14(2) te uredbe, ki jih ne zajema Priloga I k tej uredbi, se skladnost s členom 3 Uredbe (ES) št. 1935/2004 ocenjuje v skladu z mednarodno uveljavljenimi znanstvenimi načeli o oceni tveganja.
Amendments of EU acts
Spremembe aktov EU
The Annex to Council Directive 85/572/EEC [18] is replaced by the following:‘The food simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with a single food or specific groups of foods are set out in point 3 of Annex III to Commission Regulation (EU) No 10/2011.’
Priloga k Direktivi Sveta 85/572/EGS [18] se nadomesti z:„Modelne raztopine, ki se uporabljajo za preskušanje migracije sestavin polimernih materialov in izdelkov, namenjenih za stik s posameznim živilom ali posebno skupino živil, so navedene v točki 3 Priloge III k Uredbi Komisije (EU) št. 10/2011.“
Repeal of EU acts
Razveljavitev aktov EU
Directives 80/766/EEC, 81/432/EEC, and 2002/72/EC are hereby repealed with effect from 1 May 2011.
Direktive 80/766/EGS, 81/432/EGS in 2002/72/ES se razveljavijo z učinkom od 1. maja 2011.
References to the repealed Directives shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex VI.
Sklicevanja na razveljavljene direktive se štejejo za sklicevanja na to uredbo in se berejo v skladu s korelacijskimi tabelami iz Priloge VI.
Until 31 December 2012 the supporting documents referred to in Article 16 shall be based on the basic rules for overall and specific migration testing set out in the Annex to Directive 82/711/EEC.
Do 31. decembra 2012 temeljijo spremni dokumenti iz člena 16 na temeljnih pravilih za preskušanje celotne in specifične migracije iz priloge k Direktivi 82/711/EGS.
As from 1 January 2013 the supporting documents referred to in Article 16 for materials, articles and substances placed on the market until 31 December 2015, may be based on:
Od 1. januarja 2013 lahko spremni dokumenti iz člena 16 za materiale, izdelke in snovi, dane v promet do 31. decembra 2015, temeljijo na:
the rules for migration testing set out in Article 18 of this Regulation; or
pravilih za migracijske preskuse iz člena 18 te uredbe ali
the basic rules for overall and specific migration testing set out in the Annex to Directive 82/711/EEC.
temeljnih pravilih za preskušanje celotne in specifične migracije iz priloge k Direktivi 82/711/EGS.
As from 1 January 2016, the supporting documents referred to in Article 16 shall be based on the rules for migration testing set out in Article 18, without prejudice to paragraph 2 of this Article.
Brez poseganja v odstavek 2 tega člena od 1. januarja 2016 spremni dokumenti iz člena 16 temeljijo na pravilih za migracijske preskuse iz člena 18.
Until 31 December 2015 additives used in glass fibre sizing for glass fibre reinforced plastics which are not listed in Annex I have to comply with the risk assessment provisions set out in Article 19.
Aditivi, ki se uporabljajo v vezivu iz steklenih vlaken za polimerne materiale, ki so ojačani s steklenimi vlakni in niso navedeni v Prilogi I, morajo do 31. decembra 2015 izpolnjevati določbe o oceni tveganja iz člena 19.
Materials and articles that have been lawfully placed on the market before 1 May 2011 may be placed on the market until 31 December 2012.
Materiali in izdelki, ki so bili zakonito dani v promet pred 1. majem 2011, se lahko dajejo v promet do 31. decembra 2012.
The provision of Article 5 as regards the use of additives, others than plasticisers, shall apply for plastic layers or plastic coatings in caps and closures referred to in Article 2(1)(d), as from 31 December 2015.
Določba iz člena 5 o uporabi aditivov, ki niso mehčalci, se za plasti iz polimernih materialov ali plastificirane plasti za pokrovčke in zaporke iz člena 2(1)(d) uporablja od 31. decembra 2015.
The provision of Article 5 as regards the use of additives used in glass fibre sizing for glass fibre reinforced plastics, shall apply from 31 December 2015.
Določba iz člena 5 o uporabi aditivov, ki se uporabljajo v vezivu iz steklenih vlaken za polimerne materiale, ojačane s steklenimi vlakni, se uporablja od 31. decembra 2015.
The provisions of Articles 18(2), 18(4) and 20 shall apply from 31 December 2012.
Določbe iz člena 18(2) in (4) ter člena 20 se uporabljajo od 31. decembra 2012.
This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
Ta uredba je v skladu s Pogodbama v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
OJ L 354, 31.12.2008, p. 34.
UL L 354, 31.12.2008, str. 34.
SCF opinion of 4 December 2002 on the introduction of a Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials.http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf
Mnenje Znanstvenega odbora za prehrano z dne 4. decembra 2002 o uvedbi faktorja redukcije (zaužitja) maščob (FRF) v oceno izpostavljenosti migrantu iz materialov za stik z živili.http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf.
Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to the introduction of a Fat (consumption) Reduction Factor for infants and children, The EFSA Journal (2004) 103, 1-8.
Mnenje Znanstvenega odbora o aditivih za živila, aromah, pomožnih tehnoloških sredstvih in materialih za stik z živili (AFC) se je na zahtevo Komisije navezovalo na uvedbo faktorja redukcije (zaužitja) maščobe za dojenčke in otroke, The EFSA Journal (2004) 103, 1-8.
Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids
Seznam Unije za odobrene monomere, druge izhodne snovi, makromolekule, pridobljene z mikrobno fermentacijo, aditive in pomožna sredstva za polimerizacijo
Table 1 contains the following information:
V preglednici 1 so naslednje informacije:
Column 1 (FCM substance No): the unique identification number of the substance
stolpec 1 (Št. snovi FCM (materiali, namenjeni za stik z živili, food contact materials)): enotna identifikacijska številka snovi;
Column 2 (Ref. No): the EEC packaging material reference number
stolpec 2 (ref. št.): referenčna številka EGS embalažnega materiala;
Column 3 (CAS No): the Chemical Abstracts Service (CAS) registry number
stolpec 3 (št. CAS): registrska številka po CAS (Služba za izmenjavo kemijskih izvlečkov, Chemical Abstracts Service);
Column 4 (Substance Name): the chemical name
stolpec 4 (ime snovi): kemijsko ime;
Column 5 (Use as additive or polymer production aid (PPA) (yes/no)): an indication if the substance is authorised to be used as additive or polymer production aid (yes) or if the substance is not authorised to be used as additive or polymer production aid (no).
stolpec 5 (uporabljena kot aditiv ali pomožno sredstvo za polimerizacijo (da/ne)): navedba, ali se snov lahko uporablja kot aditiv ali pomožno sredstvo za polimerizacijo (da) ali pa se snov ne sme uporabljati kot aditiv ali pomožno sredstvo za polimerizacijo (ne).
If the substance is only authorised as PPA it is indicated (yes) and in the specifications the use is restricted to PPA.
Če je snov odobrena le kot pomožno sredstvo za polimerizacijo, se to navede (da), pri čemer je v specifikacijah uporaba omejena na pomožna sredstva za polimerizacijo;
Column 6 (Use as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes/no)): an indication if the substance is authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (yes) or if the substance is not authorised to be used as monomer or other starting substance or macromolecule obtained from microbial fermentation (no).
stolpec 6 (uporabljena kot monomer ali druga izhodna snov ali makromolekula, pridobljena z mikrobno fermentacijo (da/ne)): navedba, ali se snov lahko uporablja kot monomer ali druga izhodna snov ali makromolekula, pridobljena z mikrobno fermentacijo (da), ali pa se snov ne sme uporabljati kot monomer ali druga izhodna snov ali makromolekula, pridobljena z mikrobno fermentacijo (ne).
If the substance is authorised as macromolecule obtained from microbial fermentation it is indicated (yes) and in the specifications it is indicated that the substance is a macromolecule obtained from microbial fermentation.
Če je snov odobrena kot makromolekula, pridobljena z mikrobno fermentacijo, se to navede (da), pri čemer se v specifikacijah opredeli, da je snov makromolekula, pridobljena z mikrobno fermentacijo;
Column 7 (FRF applicable (yes/no)): an indication if for the substance the migration results can be corrected by the Fat Consumption Reduction Factor (FRF) (yes) or if they cannot be corrected by the FRF (no).
stolpec 7 (FRF se uporablja (da/ne)): navedba, ali se lahko rezultati preskusa migracije za snov popravijo s faktorjem redukcije maščob (FRF, Fat Reduction Factor) (da) ali pa se s faktorjem FRF ne smejo popraviti (ne);
Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance.
stolpec 8 (SML (mg/kg)): mejna vrednost specifične migracije za snov.
It is expressed in mg substance per kg food.
Izražena je v miligramih snovi na kilogram živila.
It is indicated ND if the substance shall not migrate in detectable quantities.
Če se snov izloča v nezaznavnih količinah, se to navede kot ND;
Column 9 (SML(T) [mg/kg] (group restriction No)): contains the identification number of the group of substances for which the group restriction in Column 1 in Table 2 of this Annex applies.
stolpec 9 (SML(T) [mg/kg] (skupinska omejitev št.)): vsebuje identifikacijsko številko skupine snovi, za katere velja skupinska omejitev iz stolpca 1 preglednice 2 te priloge;
Column 10 (Restrictions and specifications): contains other restrictions than the specific migration limit specifically mentioned and it contains specifications related to the substance.
stolpec 10 (omejitve in zahteve): vsebuje druge omejitve poleg posebej navedene mejne vrednosti specifične migracije in zahteve v zvezi s snovjo.
In case detailed specifications are set out a reference to Table 4 is included.
Če so določene podrobne zahteve, se vključi sklic na preglednico 4;
Column 11 (Notes on verification of compliance): contains the Notes number which refers to the detailed rules applicable for verification of compliance for this substance included in Column 1 in Table 3 of this Annex.
stolpec 11 (opombe o preverjanju skladnosti): vsebuje številko opombe, ki se nanaša na podrobna pravila za preverjanje skladnosti te snovi iz stolpca 1 preglednice 3 v tej prilogi.