natgillin/translations-raw huggingface dataset:
Therefore, for legal certainty, there is a need to place substances Ref. No 35760 and 67180 in the appropriate section of the list of additives and re-introduce the restrictions and specifications for substances Ref. No 43480, 45200, 81760 and 88640.
Zato je treba zaradi pravne varnosti snovi pod ref. št. 35760 in 67180 uvrstiti v ustrezen oddelek seznama aditivov ter ponovno uvesti omejitve in zahteve za snovi pod ref. št. 43480, 45200, 81760 in 88640.
Epoxidised soybean oil (ESBO) is used as plasticizer in gaskets.
Epoksidirano sojino olje (ESBO) se uporablja kot mehčalec v tesnilih.
Taking into account the opinion of the Authority adopted on 16 March 2006 [10] concerning exposure of adults to ESBO used in food contact materials, it is appropriate to set a shorter deadline for the compliance of gaskets of lids with the restrictions of ESBO and its substitutes set out in Directive 2002/72/EC.
Ob upoštevanju mnenja Agencije, sprejetega 16. marca 2006 [10], o izpostavljenosti odraslih epoksidiranemu sojinemu olju, ki se uporablja v materialih, ki pridejo v stik z živili, je primerno določiti krajši rok za uskladitev tesnil pokrovov z omejitvami, ki veljajo za ESBO in njegove nadomestke, določenimi v Direktivi 2002/72/ES.
The same deadline should apply as regards the prohibition of use of azodicarbonamide.
Isti rok je treba uporabiti tudi glede prepovedi uporabe azodikarbonamida.
Certain phthalates are used as plasticizers in gaskets and in other plastic applications.
Nekateri ftalati se uporabljajo kot mehčalci v tesnilih in drugih polimernih izdelkih.
Council Directive 85/572/EEC [12] and Directive 2002/72/EC should therefore be amended accordingly.
Direktivo Sveta 85/572/EGS [12] in Direktivo 2002/72/ES je zato treba ustrezno spremeniti.
Directive 2002/72/EC is amended as follows:
Direktiva 2002/72/ES se spremeni:
This Directive shall apply to the following materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose (hereafter referred to as “plastic materials and articles”):
Ta direktiva se uporablja za materiale in izdelke, ki so kot končni izdelek namenjeni za stik z živili ali prihajajo v stik z živili in so temu namenjeni (v nadaljevanju ‚polimerni materiali in izdelki‘):
materials and articles and parts thereof consisting exclusively of plastics;
materiale in izdelke ter njihove dele, ki so sestavljeni izključno iz polimernih materialov;
plastic multi-layer materials and articles;
večplastne polimerne materiale in izdelke;
plastic layers or plastic coatings, forming gaskets in lids that together are composed of two or more layers of different types of materials.’
plasti iz polimernih materialov ali plastificirane plasti za tesnila pokrovov, ki so sestavljeni iz dveh ali več plasti različnih vrst materialov.“
Without prejudice to paragraph 2(c), this Directive shall not apply to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.’
Brez poseganja v odstavek 2(c) se ta direktiva ne uporablja za materiale in izdelke, sestavljene iz dveh plasti ali več, od katerih ena plast ali več ni sestavljena izključno iz polimernega materiala, čeprav je plast, ki prihaja v neposredni stik z živili, sestavljena izključno iz polimernega materiala.“
For the purpose of this Directive the following definitions shall apply:
V tej direktivi se uporabljajo naslednje opredelitve:
“plastic multi-layer material or article” means a plastic material or article composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by other means;
‚polimerni večplastni materiali ali izdelki‘ so polimerni materiali ali izdelki, ki so sestavljeni iz dveh ali več plasti materialov, od katerih vsaka sestoji izključno iz polimernega materiala, vezanih med seboj z lepili ali s kakšnim drugim sredstvom;
“plastic functional barrier” means a barrier consisting of one or more layers of plastics which ensures that the finished material or article complies with Article 3 of Regulation (EC) No 1935/2004 of the European Parliament and of the Council and with this Directive;
‚polimerna funkcionalna pregrada‘ je pregrada, ki je sestavljena iz ene ali več plasti polimernega materiala, kar zagotavlja, da je končni material ali izdelek v skladu s členom 3 Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 in s to direktivo;
“non-fatty foods” means foods for which in migration testing simulants other than simulant D are laid down in Directive 85/572/EEC.
‚nemastna živila‘ so živila, za katere so v Direktivi 85/572/EGS določene druge raztopine za preskušanje migracij kot modelna raztopina D.
Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 60 milligrams of the constituents released per kilogram of foodstuff or food simulant (mg/kg) (overall migration limit).
Sestavine polimernih materialov in izdelkov ne smejo migrirati v živila v količinah, ki presegajo 60 miligramov sestavin, sproščenih na kilogram živila ali modelno raztopino za živila (mg/kg) (mejna vrednost celotne migracije).
However, this limit shall be 10 milligrams per square decimetre of surface area of material or article (mg/dm2) in the case of the following:
Vendar je ta meja 10 miligramov na kvadratni decimeter površine materiala ali izdelka (mg/dm2) v naslednjih primerih:
articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 millilitres (ml) or more than 10 litres (l);
pri izdelkih, kakršne so posode ali ki so podobni posodam ali ki jih je mogoče napolniti in imajo prostornino manj kot 500 mililitrov (ml) ali več kot 10 litrov (l);
sheet, film or other material or articles which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such material or article and the quantity of food in contact therewith.
pri ploščah, filmih ali drugih materialih ali izdelkih, ki jih ni mogoče napolniti ali za katere je težko določiti razmerje med površino materiala ali izdelka in količino živila v stiku z materialom ali izdelkom.
For plastic materials and articles intended to be brought into contact with or already in contact with food intended for infants and young children, as defined by Commission Directives 91/321/EEC and 96/5/EC, the overall migration limit shall always be 60 mg/kg.
Pri materialih in izdelkih, ki so namenjeni za stik z živili za dojenčke in majhne otroke ali so že v stiku z njimi, kot je opredeljeno v Direktivi Komisije 91/321/EGS in Direktivi Komisije 96/5/ES, je mejna vrednost celotne migracije vedno 60 mg/kg.
In Article 4(2), the date of ‘1 July 2006’ is replaced by ‘1 April 2008’.
V členu 4(2) se datum „1. julij 2006“ nadomesti z „1. april 2008“.
The following Articles 4c, 4d and 4e are inserted:
Vstavijo se naslednji členi 4c, 4d in 4e:
‘Article 4c
„Člen 4c
For the use of additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c), the following rules shall apply:
Za uporabo aditivov za proizvodnjo plasti iz polimernih materialov ali plastificiranih pokrovov iz člena 1(2)(c) se uporabljajo naslednja pravila:
for the additives listed in Annex III, the restrictions and/or specifications on their use set out in that Annex shall apply, without prejudice to Article 4(2);
za aditive, ki so vključeni v Prilogo III, se brez poseganja v člen 4(2) uporabljajo omejitve in/ali zahteve glede njihove uporabe iz Priloge III;
by way of derogation from Article 4(1) and Article 4a(1) and (5), additives not listed in Annex III may continue to be used, until further review, subject to national law;
z odstopanjem od člena 4(1), in člena 4a(1) in (5), se aditivi, ki niso vključeni v Prilogo III, do naslednje proučitve še naprej uporabljajo v skladu z nacionalno zakonodajo;
by way of derogation from Article 4b Member States may continue to authorise additives for the manufacture of plastic layers or plastic coatings in lids referred to in Article 1(2)(c) at national level.
z odstopanjem od člena 4b lahko države članice na nacionalni ravni še naprej odobrijo aditive za proizvodnjo polimernih plasti iz polimernih materialov ali plastificiranih pokrovov iz člena 1(2)(c).
For the use of additives exclusively acting as polymerisation production aids which are not intended to remain in the finished article (hereinafter PPAs), for the manufacture of plastic materials and articles, the following rules shall apply:
Za uporabo aditivov, ki imajo izključno vlogo pomožnih sredstev za polimerizacijo, ki se ne smejo ohraniti v končnem izdelku (v nadaljevanju ‚PPA‘) za proizvodnjo polimernih materialov in izdelkov, se uporabljajo naslednja pravila:
for the PPAs listed in Annex III, the restrictions and/or specifications on their use set out in Annex III shall apply, without prejudice to Article 4(2);
za PPA, ki so vključeni v Prilogo III, se brez poseganja v člen 4(2) uporabljajo omejitve in/ali zahteve glede njihove uporabe iz Priloge III;
by way of derogation from Article 4(1) and Article 4a(1) and (5), the PPAs not listed in Annex III may continue to be used, until further review, subject to national law;
z odstopanjem od člena 4(1) in člena 4a(1) in (5), se lahko PPA, ki niso vključeni v Prilogo III, do naslednje proučitve še naprej uporabljajo v skladu z nacionalno zakonodajo;
by way of derogation from Article 4b, Member States may continue to authorise PPAs at national level.
z odstopanjem od člena 4b lahko države članice še naprej odobrijo PPA na nacionalni ravni.
The use of azodicarbonamide, Ref. No 36640 (CAS No 000123-77-3) in the manufacture of plastic materials and articles is prohibited.’
Pri proizvodnji polimernih materialov in izdelkov je uporaba azodikarbonamida, ref. št. 36640 (št. CAS 000123-77-3) prepovedana.“
In Article 5a paragraph 2 is replaced by the following:
Drugi odstavek člena 5a se nadomesti z naslednjim:
At the marketing stages other than the retail stages, plastic materials and articles which are intended to be placed in contact with foodstuffs and which contain additives referred to in paragraph 1 shall be accompanied by a written declaration containing the information referred to in Article 9.’
V fazah trženja, razen v fazi maloprodaje, se polimernim materialom in izdelkom, namenjenih za stik z živili in ki vsebujejo aditive, navedene v odstavku 1, priloži pisna izjava, ki vsebuje informacije iz člena 9.“
In Article 7 the following paragraph is added:
Členu 7 se doda naslednji tretji odstavek:
‘For 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 91/321/EEC and 96/5/EC, the SMLs shall always be applied as mg/kg.’
„Pri polimernih materialih in izdelkih, ki so namenjeni za stik z živili za dojenčke in majhne otroke ali so že v stiku z njimi, kot je opredeljeno v Direktivi Komisije 91/321/EGS in Direktivi Komisije 96/5/ES, se SML vedno uporablja v razmerju mg/kg.“
The following Article 7a is inserted:
Vstavi se naslednji člen 7a:
In a plastic multi-layer material or article, the composition of each plastic layer shall comply with this Directive.
Pri polimernih večplastnih materialih ali izdelkih je sestava vsake plasti iz polimernih materialov v skladu s to direktivo.
By way of derogation from paragraph 1, a layer which is not in direct contact with food and is separated from the food by a plastic functional barrier, may, provided that the finished material or article complies with the specific and overall migration limits specified in this Directive:
Z odstopanjem od odstavka 1 lahko za plast, ki ni v neposrednem stiku z živilom in jo od živila ločuje polimerna funkcionalna pregrada, vendar je končni material ali izdelek v skladu z mejnimi vrednostmi specifične in celotne migracije iz te direktive, velja:
not comply with the restrictions and specifications set in this Directive,
da ni v skladu z omejitvami in zahtevami iz te direktive; in/ali
be manufactured with substances other than those included in this Directive or in the national lists concerning the plastic materials and articles intended to come into contact with food.
da je proizvedena iz snovi, ki niso vključene v to direktivo ali v nacionalne sezname v zvezi s polimernimi materiali in izdelki, namenjenimi za stik z živili.
The migration of the substances referred to in paragraph 2(b) into food or simulant shall not exceed 0,01 mg/kg, measured with statistical certainty by a method of analysis in accordance with Article 11 of Regulation (EC) No 882/2004 of the European Parliament and of the Council.
Migracija snovi iz odstavka 2(b) v živilo ali modelno raztopino ne presega 0,01 mg/kg, merjeno s statistično natančnostjo z analizno metodo v skladu s členom 11 Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta.
This limit shall always be expressed as concentration in foods or simulants.
Ta mejna vrednost je vedno izražena kot koncentracija v živilu ali modelni raztopini.
It shall apply to a group of compounds, if they are structurally and toxicologically related, in particular isomers or compounds with the same relevant functional group, and shall include possible set-off transfer.
Uporablja se za skupino spojin, če so strukturno in toksikološko povezane, še posebej izomeri ali spojine z enako ustrezno funkcionalno skupino, ter vključuje možno nezaželeno prepuščanje.
The substances referred to in paragraph 2(b) shall not belong to either of the following categories:
Snovi iz odstavka 2(b) niso vključene v naslednje kategorije:
substances classified as proved or suspect “carcinogenic”, “mutagenic” or “toxic to reproduction” substances in Annex I to Council Directive 67/548/EEC;
snovi, razvrščene kot dokazano ali domnevno ‚rakotvorne‘, ‚mutagene‘ ali ‚strupene za razmnoževanje‘ v Prilogi I k Direktivi Sveta 67/548/EGS; ali
substances classified under the self-responsibility criteria as ‘carcinogenic’, ‘mutagenic’ or ‘toxic to reproduction’ according to the rules of Annex VI to Directive 67/548/EEC.
snovi, ki so označene kot ‚rakotvorne‘, ‚mutagene‘ ali ‚strupene za razmnoževanje‘na osnovi upoštevanja lastnih meril, v skladu s pravili iz Priloge VI Direktive 67/548/EGS.
In Article 8 the following paragraph 5 is added:
Členu 8 se doda naslednji odstavek 5:
Notwithstanding paragraph 1, for phthalates (Ref. No 74640, 74880, 74560, 75100, 75105) referred to in Annex III Section B, the verification of the SML shall only be performed in food simulants.
Ne glede na odstavek 1 se za ftalate (pod ref. št. 74640, 74880, 74560, 75100, 75105) iz oddelka B Priloge III preverjanje SML izvaja le v modelnih raztopinah za živila.
However, verification of the SML may be performed in food where the food has not already been in contact with the material or article and is pre-tested for the phthalate and the level is not statistically significant or greater than or equal to the limit of quantification.’
Vendar pa se preverjanje SML lahko izvaja v živilih, v katerih hrana še ni prišla v stik z materialom ali izdelkom in je bila pred tem testirana na ftalat in ta raven ni statistično pomembna ali večja ali enaka meji določanja.“
At the marketing stages other than the retail stage, plastic materials and articles as well as the substances intended for the manufacturing of those materials and articles, shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004.
V fazah trženja, razen pri maloprodaji, je polimernim materialom in izdelkom ter snovem, namenjenim za proizvodnjo teh materialov in izdelkov, priložena pisna izjava v skladu s členom 16 Uredbe (ES) št. 1935/2004.
The declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex VIa.
To izjavo izda nosilec dejavnosti in vključuje informacije, določene v Prilogi VIa.
Appropriate documentation to demonstrate that the materials and articles as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Directive 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 ter snovi, namenjene za proizvodnjo teh materialov in izdelkov, v skladu z zahtevami te direktive.
That documentation shall contain the conditions and results of testing, calculations, other analysis, and evidence on the safety or reasoning demonstrating compliance.’
Ta dokumentacija vključuje pogoje in rezultate preskušanj, izračune, druge analize ter dokaze o varnosti ali utemeljitve, ki dokazujejo skladnost.“
Annexes I, II and III are amended in accordance with Annexes I, II and III to this Directive.
Priloge I, II in III se spremenijo v skladu s prilogami I, II in III k tej direktivi.
The text in Annex IV to this Directive is inserted as Annex IVa.
Besedilo v Prilogi IV k tej direktivi se vstavi kot Priloga IVa.
Annexes V and VI are amended in accordance with Annexes V and VI to this Directive.
Prilogi V in VI se spremenita v skladu s prilogama V in VI k tej direktivi.
The text in Annex VII to this Directive is inserted as Annex VIa.
Besedilo v Prilogi VII k tej direktivi, se vstavi v skladu s Prilogo VIa.
The Annex to Directive 85/572/EEC is amended in accordance with Annex VIII to this Directive.
Priloga k Direktivi 85/572/EGS se spremeni v skladu s Prilogo VIII k tej direktivi.
Member States shall adopt and publish, by 1 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 1. aprila 2008 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji takoj predložijo besedila teh predpisov ter razpredelnico za primerjavo predpisov in te direktive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.
Ko države članice sprejmejo te predpise, se v teh predpisih sklicujejo na to direktivo ali je takšno sklicevanje navedeno ob njihovi uradni objavi.
They shall apply those provisions in such a way as to:
Te predpise uporabljajo tako, da je:
permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with Directive 2002/72/EC, as amended by this Directive, from 1 April 2008;
omogočeno trgovanje s polimernimi materiali in izdelki, namenjenimi za stik z živili, ki so v skladu z Direktivo 2002/72/ES, kakor je spremenjena s to direktivo, in njihova uporaba od 1. aprila 2008;
prohibit the manufacture and importation into the Community of lids containing a gasket which do not comply with restrictions and specifications for Ref. No 30340; 30401; 36640; 56800; 76815; 76866; 88640 and 93760 laid down in Directive 2002/72/EC as amended by this Directive from 1 June 2008;
prepovedana proizvodnja in uvoz pokrovov v Skupnost, ki vsebujejo tesnila, ki niso v skladu z omejitvami in zahtevami za ref. št. 30340, 30401, 36640, 56800, 76815, 76866, 88640 in 93760 iz Direktive 2002/72/ES, kakor je bila spremenjena z Direktivo od 1. junija 2008;
prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food which do not comply with restrictions and specifications for phthalates Ref. No 74560; 74640; 74880; 75100; 75105 laid down in Directive 2002/72/EC as amended by this Directive from 1 June 2008;
prepovedana proizvodnja in uvoz polimernih materialov in izdelkov v Skupnost, namenjenimi za stik z živili in ki niso v skladu z omejitvami in zahtevami za ftalate (ref. št. 74560, 74640, 74880, 75100, 75105) iz Direktive od 1. junija 2008;
without prejudice to point (b) and (c), prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food which do not comply with Directive 2002/72/EC as amended by this Directive from 1 April 2009.
brez poseganja v odstavek (b) in (c) prepovedana proizvodnja polimernih materialov in izdelkov, namenjenih za stik z živili, ki niso v skladu z Direktivo 2002/72/ES, kakor je spremenjena s to direktivo, in njihov uvoz v Skupnost od 1. aprila 2009.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice predložijo Komisiji besedilo glavnih določb nacionalne zakonodaje, sprejetih na področju, ki jih zajema ta direktiva.
Directive as last amended by Directive 2005/79/EC (OJ L 302, 19.11.2005, p. 35).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2005/79/ES (UL L 302, 19.11.2005, str. 35).
The EFSA Journal (2005) 219, 1-36.
Bilten EFSA (2005) 219, 1–36.
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, Bilten EFSA (2004) 103, 1–8.
The EFSA Journal (2005) 218, 1-9.The EFSA Journal (2005) 248, 1-16.The EFSA Journal (2005) 273, 1-26.The EFSA Journal (2006) 316 to 318, 1-10.The EFSA Journal (2006) 395 to 401, 1-21.
Bilten EFSA (2005) 218, 1–9.Bilten EFSA (2005) 248, 1–16.Bilten EFSA (2005) 273, 1–26.Bilten EFSA (2006) 316–318, 1–10.Bilten EFSA (2006) 395–401, 1–21.
The EFSA Journal (2006) 332, 1-9.
Bilten EFSA (2006) 332, 1–9.
The EFSA Journal (2005) 244, 1-18.The EFSA Journal (2005) 245, 1-14.The EFSA Journal (2005) 243, 1-20.The EFSA Journal (2005) 242, 1-17.The EFSA Journal (2005) 241, 1-14.
Bilten EFSA (2005) 244, 1–18.Bilten EFSA (2005) 245, 1–14.Bilten EFSA (2005) 243, 1–20.Bilten EFSA (2005) 242, 1–17.Bilten EFSA (2005) 241, 1–14.
OJ L 372, 31.12.1985, p. 14.
UL L 372, 31.12.1985, str. 14.
OJ L 49, 28.2.1996, p. 17.’
UL L 49, 28.2.1996, str. 17.“
OJ 196, 16.8.1967, p. 1.’
UL 196, 16.8.1967, str. 1.“
Annex I to Directive 2002/72/EC is amended as follows:
Priloga I k Direktivi 2002/72/ES se spremeni:
The following points 2a and 2b are inserted:
Vstavi se naslednji točki 2a in 2b:
Correction of specific migration in foods containing more than 20 % fat by the Fat Reduction Factor (FRF):
Popravek specifične migracije v živila, ki vsebujejo več kot 20 % maščobe, s faktorjem redukcije maščob (FRF):
“Fat Reduction Factor” (FRF) is a factor between 1 and 5 by which measured migration of lipophilic substances into a fatty food or simulant D and its substitutes shall be divided before comparison with the specific migration limits.
‚Faktor redukcije maščob‘ (FRF) je faktor med 1 in 5, s katerim se deli izmerjena migracija lipofilnih snovi v maščobno živilo ali modelno raztopino D in njene nadomestke pred primerjavo z mejnimi vrednostmi specifične migracije.
Substances considered “lipophilic” for the application of the FRF are listed in Annex IVa.
Snovi, ki se za uporabo FRF štejejo za ‚lipofilne‘, so navedene v Prilogi IVa.