natgillin/translations-raw huggingface dataset:
BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.
CAS 0000080-05-7), znana tudi kot bisfenol A (v nadaljnjem besedilu: BPA), se uporablja za proizvodnjo nekaterih materialov in izdelkov, namenjenih za stik z živili, kot so polikarbonatni polimerni materiali in epoksi smole, ki se uporabljajo v lakih in premazih.
The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011.
BPA lahko migrira v živilo iz materiala ali izdelka, s katerim je živilo v stiku, kar privede do izpostavljenosti bisfenolu A za potrošnike navedenih živil.
The authorisation is subject to a specific migration limit (SML) of 0,6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food.
Uporaba BPA kot monomera pri proizvodnji polimernih materialov in izdelkov je odobrena z Uredbo Komisije (EU) št. 10/2011.
A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.
Agencija je po objavi znanstvenega mnenja o BPA leta 2011 ugotovila, da je treba njeno oceno izpostavljenosti v mnenju iz leta 2006 glede na nove podatke posodobiti in da bi prav tako bilo treba preučiti prehransko izpostavljenost v okviru drugih načinov izpostavljenosti.
After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated.
Agencija se je odločila, da bo izvedla popolno ponovno oceno BPA na podlagi najnovejših znanstvenih dokazov.
The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence.
Leta 2012 je Agencija v skladu s členom 29(1)(b) Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta svoj znanstveni odbor za snovi v stiku z živili, encime, arome in pomožna tehnološka sredstva (CEF) zaprosila, naj pripravi znanstveno mnenje o tveganjih za javno zdravje v zvezi s prisotnostjo BPA v živilih.
In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council, the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs.
Agencija je po pregledu razpoložljivih podatkov in znanstvenih študij, objavljenih od leta 2006 do leta 2012, ter nekaj študij, ki so bile na voljo v letu 2013, 11. decembra 2014 sprejela mnenje.
The Authority adopted an opinion on 11 December 2014, having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013.
V navedenem mnenju je Agencija spremembe povprečne relativne teže ledvic v dvogeneracijski študiji na miših določila kot kritične končne točke in izračunala primerjalni odmerek (spodnja meja zaupanja) (BMDL10) v višini 8960 μg/kg telesne teže na dan.
In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8960 μg/kg bw per day.
Lahko je uporabila nove toksikokinetične podatke, ki omogočajo natančnejšo ekstrapolacijo podatkov za posamezno snov z živali na ljudi, in določila ekvivalentno dozo za ljudi (HED) pri 609 μg/kg telesne teže na dan.
It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 μg/kg bw per day.
HED je bila uporabljena kot referenčna točka za določitev orientacijske vrednosti za BPA, pri kateri se upoštevajo vplivi na zdravje.
The HED was used as a reference point for establishing a health-based guidance value for BPA.
Za določitev te orientacijske vrednosti, pri kateri se upoštevajo vplivi na zdravje, je Agencija uporabila faktor negotovosti 2,5 za razlike med vrstami in 10 za razlike znotraj vrst.
To establish this health-based guidance value, the Authority applied an uncertainty factor of 2,5 for inter-species differences and 10 for intra-species differences.
Uporabila je dodatni faktor 6 za upoštevanje negotovosti glede možnih zdravstvenih učinkov BPA na mlečno žlezo in spolne organe ter presnovni, nevrovedenjski in imunski sistem.
It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems.
Posledično je bil uporabljen skupni faktor negotovosti 150 za določitev novega dopustnega dnevnega vnosa (TDI) v višini 4 μg/kg telesne teže na dan.
As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 μg/kg bw per day.
Vendar pa je Agencija TDI opredelila kot začasni TDI (t-TDI), ki se uporablja do predvidenega izida študije dolgoročne toksičnosti BPA pri glodalcih, ki se izvaja v okviru nacionalnega programa za toksikologijo Uprave za hrano in zdravila (NTP/FDA) v Združenih državah Amerike (ZDA).
However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the United States of America (USA).
Agencija je ugotovila, da je prehranska izpostavljenost BPA nižja od t-TDI, in zaključila, da ob ocenjeni ravni izpostavljenosti javno zdravje ni ogroženo.
The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure.
Agencija je v svojem mnenju, ki ga je sprejela 11. decembra 2014, ocenila tako neprehranske kot prehranske vire izpostavljenosti.
In its opinion adopted on 11 December 2014, the Authority also estimated non-dietary sources of exposure as well as those from the diet.
Neprehranski viri vključujejo izpostavljenost prek zraka, zaužitje prahu in vnos prek kože zaradi stika s termoreaktivnim papirjem in kozmetičnimi izdelki.
Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics.
Odbor CEF je ugotovil, da so osrednje ocene za skupno izpostavljenost BPA prek prehranskih in neprehranskih virov za najbolj izpostavljene skupine, med katerimi so dojenčki, otroci in mladostniki, nižje od t-TDI ter da je raven ogroženosti javnega zdravja zaradi BPA nizka pri ocenjenih ravneh skupne izpostavljenosti.
The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure.
Po mnenju, ki ga je Agencija objavila v letu 2014, bi bilo treba sedanjo vrednost SML za polimerne materiale in izdelke posodobiti, da se upošteva nov t-TDI.
Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI.
Pri določanju SML se uporablja dogovorjena domneva, da oseba s 60 kg telesne teže na dan zaužije 1 kg hrane in da celotna izpostavljenost izhaja iz materialov, namenjenih za stik z živili.
The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials.
Člen 5(1)(e) Uredbe (ES) št. 1935/2004 določa, da bi bilo treba pri mejnih vrednosti specifičnih migracij posameznih sestavin v ali na živila ustrezno upoštevati druge možne vire izpostavljenosti navedenim sestavinam.
Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents.
Agencija je ugotovila, da lahko izpostavljenost, ki izhaja iz neprehranskih virov BPA, znatno prispeva k skupni izpostavljenosti za nekatere skupine prebivalstva, ter da poleg neprehranskih virov k izpostavljenosti BPA za več skupin prebivalstva pomembno prispevajo še nekonzervirano meso in mesni proizvodi.
The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups.
V takih primerih, v katerih viri, ki niso materiali, namenjeni za stik z živili, lahko znatno prispevajo k morebitni skupni izpostavljenosti snovi, ni primerno določiti celotnega TDI za materiale, namenjene za stik z živili, in treba bi bilo uporabiti nižjo vrednost.
In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used.
Ob upoštevanju dogovorjene domneve o uporabi faktorjev dodelitve za materiale, namenjene za stik z živili, vključno z dejstvom, da skupna izpostavljenost ne presega t-TDI, in ob upoštevanju faktorja negotovosti 150 pri izpeljavi t-TDI, ter vključno s podatki iz mnenja Agencije o virih BPA, ki niso materiali v stiku z živili, se faktor dodelitve v višini 20 % šteje za ustreznega pri določanju SML.
Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20 % is considered appropriate when setting the SML.
Zato bi bilo treba za polimerne materiale in izdelke na podlagi t-TDI, faktorja dodelitve in domneve o izpostavljenosti določiti vrednost SML pri 0,05 mg BPA na kg živila (mg/kg), da se zagotovi, da izpostavljenost BPA ostane nižja od t-TDI in ne ogroža zdravja ljudi.
Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health.
Čeprav SML, določen ob upoštevanju mnenja, služi kot podlaga za celovito obvladovanje tveganj, ki jih povzroča BPA iz materialov, s katerimi je živilo v stiku, pa še vedno obstajajo negotovosti, ki so opredeljene v navedenem mnenju.
While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion.
Glede na novi študiji o razvojni imunotoksičnosti BPA je Agencija v letu 2016 navedla, da novi dokaz, predstavljen v navedenih študijah, dodatno kaže na razvojno imunotoksičnost BPA.
With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA.
Ob upoštevanju obsega znanstvene negotovosti in narave morebitnih škodljivih učinkov, zlasti razvojnih, bi bilo treba glede na ranljivejše skupine prebivalstva, zlasti dojenčke in majhne otroke, pri katerih bi razvojni učinki lahko bili nepovratni in doživljenjski, sprejeti nadaljnje previdnostne ukrepe.
Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time.
Previdnostno načelo iz člena 7 Uredbe (ES) št. 178/2002 dovoljuje sprejetje začasnih ukrepov na podlagi razpoložljivih ustreznih informacij, dokler niso na voljo rezultati, povezani s trajno negotovostjo, ter do dodatne ocene tveganja in pregleda ukrepov v primernem roku.
The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time.
Komisija lahko sprejme preventivne ukrepe glede uporabe BPA na podlagi previdnostnega načela, ki se uporablja v primeru znanstvene negotovosti, tudi če tveganje, zlasti za zdravje ljudi, ni bilo v celoti dokazano.
The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated.
V ta namen BPA ne bi smeli uporabljati v proizvodnji polikarbonatnih skodelic ali stekleničk za pitje, namenjenih za dojenčke in majhne otroke, kakor so opredeljeni v Uredbi (EU) št. 609/2013 Evropskega parlamenta in Sveta.
In order to do so, BPA should not be used to manufacture polycarbonate drinking cups or bottles which are intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council.
Poleg polimernih materialov, ki so namenjeni za stik z živili, se BPA obsežno uporablja v epoksi smolah za lake in premaze, zlasti za njihovo nanašanje na notranjost pločevink za živila.
In addition to its use in plastic food contact materials, BPA is used extensively in epoxy resins for varnishes and coatings, particularly for application on the interior of food cans.
Medtem ko so bili za BPA v polimernih materialih in izdelkih sprejeti posebni ukrepi, določeni v členu 5 Uredbe (ES) št. 1935/2004, pa taki ukrepi niso bili sprejeti za BPA v lakih in premazih na ravni Unije.
While specific measures provided for in Article 5 of Regulation (EC) No 1935/2004 have been adopted as regards BPA in plastic materials and articles, such measures have not been adopted as regards BPA in varnishes and coatings at the Union level.
Zato so države članice v skladu s členom 6 navedene uredbe lahko ohranile ali sprejele nacionalne določbe o BPA v lakih in premazih, pod pogojem, da so navedeni ukrepi skladni s pravili iz Pogodb.
Therefore, in accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national provisions on BPA in varnishes and coatings provided those measures comply with the rules laid down in the Treaties.
Glede na to, da so države članice uvedle različne nacionalne ukrepe, ki se uporabljajo za BPA v materialih, namenjenih za stik z živili, in glede na posledične tehnične in praktične obremenitve, o katerih poroča industrija, ter ob upoštevanju prispevka k prehranski izpostavljenosti BPA iz konzerviranih živil, opredeljenega v mnenju Agencije iz leta 2014, in obsežne uporabe BPA v epoksi smolah za lake in premaze, ki se nanašajo na pločevinke za živila, je prav tako primerno določiti vrednost omejitev za BPA, ki se uporablja v lakih in premazih.
In light of the introduction by Member States of divergent national measures applicable to BPA in food contact materials and the resulting technical and practical burdens reported by industry, and having regard to the contribution to dietary exposure of BPA from canned food identified in the Authority's opinion of 2014 and the extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropriate to establish restrictions for BPA used in varnishes and coatings.
Ista domneva glede izpostavljenosti BPA iz polimernih materialov in izdelkov se uporablja za lake in premaze.
The same assumption concerning exposure to BPA from plastic materials and articles applies to varnishes and coatings.
Za zagotovitev učinkovitega delovanja notranjega trga in zagotovitev visoke ravni varovanja zdravja ljudi bi bilo treba vrednost SML, določeno za BPA v polimernih materialih in izdelkih, uporabljati tudi za lake in premaze, ki se nanašajo na materiale in izdelke, kadar je bil navedeni lak ali premaz proizveden z uporabo BPA.
In order to ensure the effective functioning of the internal market and to ensure a high level of protection for human health, the SML established for BPA from plastic materials and articles should also apply to varnishes and coatings applied to materials and articles, where that varnish or coating has been produced using BPA.
Ker se BPA lahko uporablja v embalaži živil za dojenčke in majhne otroke, BPA ne bi smel prehajati iz lakov in premazov, ki se nanašajo na materiale ali izdelke, posebej namenjene za stik z živili za dojenčke in majhne otroke, kakor so opredeljeni v Uredbi (EU) št 609/2013, zlasti z začetnimi in nadaljevalnimi formulami za dojenčke, predelanimi žiti, hrano za dojenčke, živili za posebne zdravstvene namene, ki so bila pripravljena za zadovoljitev prehranskih potreb dojenčkov in majhnih otrok, ali mlečnimi napitki in podobnimi proizvodi, posebej namenjenimi majhnim otrokom.
As BPA may be used in food packaging containing foods for infants and young children, BPA should not migrate from varnishes and coatings applied to materials or articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.
V povezavi z določitvijo vrednosti omejitev za lake in premaze je prav tako treba opredeliti pravila za preverjanje skladnosti z navedeno vrednostjo omejitev.
In conjunction with the establishment of restrictions for varnishes and coatings, it is also necessary to define rules for verification of compliance with the restrictions.
Zlasti bi bilo treba določiti pravila za migracijske preskuse in pravila za izražanje rezultatov migracijskih preskusov.
In particular, rules for migration testing and rules for expression of migration testing results should be established.
Zato je primerno določiti taka pravila za preverjanje skladnosti z vrednostjo omejitev za lake in premaze, ki se nanašajo na materiale in izdelke, pri katerih so bili navedeni laki ali premazi proizvedeni z uporabo BPA.
Therefore it is appropriate to establish such rules for checking compliance with the restrictions for varnishes and coatings applied to materials and articles where those varnishes or coatings have been produced using BPA.
Uredba (EU) št. 10/2011 določa celovit okvir za preverjanje skladnosti polimernih materialov, namenjenih za stik z živili, z opredeljenimi vrednostmi omejitev, vključno s pravili za izražanje rezultatov migracijskih preskusov.
Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results.
Laki in premazi, ki se nanašajo na materiale in izdelke, nimajo posebnih značilnosti, ki bi zahtevale vzpostavitev različnih ali bolj specifičnih določb, zato je primerno razširiti uporabo pravil iz Uredbe (EU) št. 10/2011 na preverjanje skladnosti lakov in premazov, ki se nanašajo na materiale in izdelke, z določenimi vrednostmi omejitev.
As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions.
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.
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.
Odgovorni nosilec dejavnosti bi moral pri proizvodnji lakiranega ali premazanega materiala ali izdelka dokumentirati skladnost z veljavnimi pravili v izjavi o skladnosti, ki je nato na voljo njegovim strankam.
On production of the varnished or coated material or article, the responsible business operator should document compliance with the applicable rules in a declaration of compliance which is made available to their customers.
Za zagotovitev, da izjava zagotavlja dovolj informacij, ki omogočajo preverjanje skladnosti, je primerno opredeliti informacije, ki jih je treba vključiti v izjavo.
In order to ensure that the declaration provides sufficient information to enable verification of compliance, it is appropriate to specify the information that must be included in the declaration.
Poleg tega bi morali pristojni organi imeti možnost, da preverijo skladnost z veljavnimi pravili.
In addition, competent authorities should be able to verify compliance with the applicable rules.
Od nosilcev dejavnosti bi zato bilo treba zahtevati, da pristojnim organom dajo na voljo ustrezna dokazila, ki utemeljuje izjavo o skladnosti.
Business operators should therefore be required to make available for the competent authorities appropriate supporting documentation, substantiating the declaration of compliance.
Da se nosilcem dejavnosti zagotovi dovolj časa za prilagoditev njihovih proizvodnih postopkov skladno z omejitvami ter za zmanjšanje upravnega in finančnega bremena zaradi takšne prilagoditve, je primerno odložiti uporabo te uredbe in dovoliti, da materiali in izdelki, ki so bili zakonito dani na trg pred datumom začetka uporabe te uredbe, ostanejo na trgu do izčrpanja zalog.
In order to ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this Regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this Regulation to remain on the market until the exhaustion of stocks.
Uredbo (EU) št. 10/2011 bi bilo zato treba ustrezno spremeniti.
For the purposes of this Regulation, the following definitions shall apply:
„mejna vrednost specifične migracije“ (SML, specific migration limit) pomeni največjo dovoljeno količino posamezne snovi, ki se iz materiala ali izdelka izloči v živila ali simulante za živila;
‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;
„materiali in izdelki“ pomenijo vse materiale ali izdelke, ki spadajo v eno od kategorij iz člena 1(2) Uredbe (ES) št. 1935/2004;
‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;
„laki“ ali „premazi“ pomenijo materiale ali izdelke, ki so sestavljeni iz ene ali več nesamonosilnih plasti, proizvedenih z uporabo 2,2-bis(4-hidroksifenil)propana (BPA), in se nanašajo na materiale ali izdelke ter jim dajo posebne lastnosti ali izboljšajo njihovo tehnično zmogljivost.
‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance.
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