natgillin/translations-raw huggingface dataset:
Intelligent systems may be positioned on the outer surface of the package and may be separated from the food by a functional barrier, which is a barrier within food contact materials or articles preventing the migration of substances from behind that barrier into the food.
Inteligentni sistemi so lahko nameščeni na zunanjo površino embalaže in od živil ločeni s funkcionalno pregrado, to je pregrada v materialih ali izdelkih za stik z živili, ki preprečuje migracijo snovi skozi to pregrado v živila.
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 določeno mejno vrednostjo zaznavnosti.
Taking into account foods for infants and other particularly susceptible persons, as well as the difficulties of this type of analysis affected by a large analytical tolerance, 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 občutljive osebe ter težav pri tej vrsti analize, pri kateri je merilna negotovost velika, bi bilo treba v živilih za migracijo nedovoljene snovi skozi funkcionalno pregrado določiti mejno vrednost 0,01 mg/kg.
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 v veliki meri drugačne kot pri istih snoveh z večjimi delci, bi bilo treba oceniti od primera do primera glede na tveganje, dokler ni na voljo več podatkov o tej novi tehnologiji.
Therefore, they should not be covered by the functional barrier concept.
Koncept funkcionalne pregrade teh snovi torej ne bi smel zajeti.
The specific Community measure covering the passive part of an active or intelligent material may lay down requirements for the inertness of the material, for example, an overall migration limit applicable to plastic materials.
Posebni ukrep Skupnosti, ki zajema pasivni del aktivnega ali inteligentnega materiala, lahko določi zahteve za inertnost materiala, na primer za mejno vrednost celotne migracije, ki se uporablja za plastične materiale.
If a releasing active component is incorporated into a food contact material covered by a specific Community measure, there may be a risk of exceeding the overall migration limit due to the release of the active substance.
Če je aktivna sestavina, ki sprošča, vključena v material za stik z živili, ki ga zajema poseben ukrep Skupnosti, lahko obstaja tveganje, da se preseže mejna vrednost celotne migracije zaradi sprostitve aktivne snovi.
As the active function is not an inherent feature of the passive material, the amount of released active substance should not be calculated in the value of overall migration.
Ker aktivno delovanje ni neločljivo povezano s pasivnim materialom, se količina aktivne snovi, ki se sprošča, ne bi smela upoštevati v vrednosti celotne migracije.
Article 4(5) of Regulation (EC) No 1935/2004 provides that active and intelligent materials and articles already brought into contact with food are to be adequately labelled to allow identification by the consumer of non-edible parts.
Člen 4(5) Uredbe (ES) št. 1935/2004 določa, da se aktivni in inteligentni materiali in izdelki, ki so že prišli v stik z živili, ustrezno označijo, da lahko potrošnik prepozna neužitne dele.
Consistency of such information is indispensable in order to avoid confusion at consumer level.
Doslednost takšnih podatkov je nujna, da bi se izognili zmedi pri potrošnikih.
Therefore, active and intelligent materials and articles should be labelled with appropriate words and accompanied, where technically possible, by a symbol, whenever materials and articles or parts of them are perceived as edible.
Zato bi bilo treba aktivne in inteligentne materiale označiti z napisom in jim priložiti, kadar je to tehnično mogoče, znak, kadar koli se materiali in izdelki ali njihovi deli lahko zaznavajo kot užitni.
Article 16 of Regulation (EC) No 1935/2004 provides that materials and articles are to be accompanied by a written declaration of compliance attesting that they comply with the rules applicable to them.
Člen 16 Uredbe (ES) št. 1935/2004 določa, da se materialom in izdelkom priloži pisna izjava o skladnosti, ki potrjuje, da izpolnjujejo predpise, ki se zanje uporabljajo.
In accordance with Article 5(1)(h) and (i) of that Regulation, to strengthen the coordination and responsibility of the suppliers at each stage of the manufacturing process, the responsible persons should document compliance with the relevant rules in a declaration of compliance which is made available to his customer.
V skladu s členom 5(1)(h) in (i) navedene uredbe bi morale za večjo usklajenost in odgovornost dobaviteljev na vsaki stopnji proizvodnega postopka odgovorne osebe v izjavi o skladnosti, ki jo dajo na voljo svoji stranki, zabeležiti skladnost z ustreznimi pravili.
In addition, at each stage of the manufacturing process, supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities.
Poleg tega bi morala biti pristojnim organom na vsaki stopnji proizvodnega postopka na voljo spremna dokumentacija, ki utemeljuje podatke v izjavi o skladnosti.
Article 17(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4] requires food business operators to verify that foods satisfy the relevant requirements of food law.
Člen 17(1) Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta [4] od nosilca živilske dejavnosti zahteva, da preveri, ali živila izpolnjujejo ustrezne zahteve živilske zakonodaje.
Article 15(1)(e) of Regulation (EC) No 1935/2004 provides that active materials and articles, which are not yet in contact with food when placed on the market, are to be accompanied by information on the permitted use or uses and other relevant information such as the name and maximum quantity of the substances released by the active component so as to enable food business operators who use these materials and articles to comply with any other relevant Community provisions or, in their absence, national provisions applicable to food, including the provisions on food labelling.
Člen 15(1)(e) Uredbe (ES) št. 1935/2004 določa, da so aktivni materiali in izdelki, ki niso v stiku z živili, ko so dani na trg, opremljeni s podatki o dovoljeni uporabi ali uporabah in drugimi pomembnimi informacijami, kot na primer ime in največja količina snovi, ki jih sprosti sestavina aktivnega materiala, ki bodo omogočile nosilcem živilske dejavnosti, ki uporabljajo te materiale in izdelke, izpolnjevanje vseh drugih ustreznih predpisov Skupnosti oziroma, če teh ni, nacionalnih predpisov, ki se uporabljajo za živila, vključno z določbami o označevanju živil.
To this end, 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 or intentional release from active and intelligent materials and articles to food complies with the specifications and restrictions laid down in Community or national provisions applicable to food.
V ta namen bi moral nosilec živilske dejavnosti ob upoštevanju načela zaupnosti imeti dostop do ustreznih podatkov, ki zagotavljajo, da je migracija iz materialov ali namerno sproščanje iz aktivnih in inteligentnih materialov in izdelkov v živila v skladu s specifikacijami in omejitvami iz predpisov Skupnosti ali nacionalnih predpisov, ki se uporabljajo za živila.
Since several active and intelligent materials and articles are already on the market in the Member States, provisions should be established to ensure that the transition to a Community authorisation procedure is smooth and does not disturb the existing market for those materials and articles.
Ker je več aktivnih in inteligentnih materialov in izdelkov v državah članicah že na trgu, bi bilo treba vzpostaviti predpise, ki bodo zagotovili, da je prehod k postopku odobritve Skupnosti nemoten in ne povzroča motenj na obstoječem trgu za navedene materiale in izdelke.
Sufficient time should be allowed for the applicant to make available the information necessary for the safety assessment of the substance or the combination of substances which constitutes the component.
Vlagatelju bi bilo treba zagotoviti dovolj časa, da zagotovi potrebne podatke za oceno varnosti snovi ali kombinacije snovi, ki sestavljajo sestavino.
Therefore, an 18 month period should be allowed, during which time the information on active and intelligent materials and articles should be submitted by the applicants.
Zato bi bilo treba zagotoviti 18-mesečno obdobje, v katerem bi moral vlagatelj posredovati podatke o aktivnih in inteligentnih materialih in izdelkih.
It should also be possible to submit applications for authorisation of a new substance or of a combination of substances during that 18 month period.
Prav tako bi moralo biti v 18-mesečnem obdobju mogoče vložiti vloge za odobritev nove snovi ali kombinacije snovi.
The Authority should evaluate, without delay, all applications for existing as well as new substances which constitute the components for which a valid application was submitted on time and in accordance with the guidelines of the Authority during the initial application phase.
Agencija bi morala nemudoma obravnavati vse vloge za obstoječe in nove snovi, ki sestavljajo sestavine, za katere je bila med začetno prijavno fazo veljavna vloga vložena pravočasno in v skladu z navodili Agencije.
A Community list of authorised substances should be drawn up by the Commission after the completion of the safety assessment of all substances for which a valid application was submitted in accordance with the guidelines of the Authority, during the initial 18 month period.
Po zaključku ocene varnosti vseh snovi, za katere je bila v začetnem 18-mesečnem obdobju vložena veljavna vloga v skladu z navodili Agencije, bi morala Komisija pripraviti seznam Skupnosti za dovoljene snovi.
In order to ensure fair and equal conditions for all applicants, this Community list should be drawn up in a single step.
Da se zagotovijo pošteni in enaki pogoji za vse vlagatelje, bi bilo treba ta seznam Skupnosti oblikovati v enem koraku.
The rules concerning the declaration of compliance and the specific labelling rules should only apply six months after the date of entry into force of this Regulation to give business operators sufficient time to adapt to these new rules.
Pravila glede izjave o skladnosti in pravila glede posebnega označevanja se uporabljajo šest mesecev po začetku veljavnosti te uredbe, da se nosilcem živilske dejavnosti zagotovi dovolj časa za prilagoditev tem novim pravilom.
This Regulation establishes specific requirements for the marketing of active and intelligent materials and articles intended to come into contact with food.
Ta uredba vzpostavlja posebne zahteve za trženje aktivnih in inteligentnih materialov in izdelkov, namenjenih za stik z živili.
These specific requirements are without prejudice to Community or national provisions applicable to the materials and articles to which active or intelligent components are added or into which they are incorporated.
Posebne zahteve ne posegajo v predpise Skupnosti ali nacionalne predpise, ki se uporabljajo za materiale in izdelke, katerim se dodajajo aktivne ali inteligentne sestavine ali so vanje vključene.
This Regulation shall apply to active and intelligent materials and articles which are placed on the market within the Community.
Ta uredba se uporablja za aktivne in inteligentne materiale in izdelke, ki so dani na trg v Skupnosti.
‘active materials and articles’ means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food;
„aktivni materiali in izdelki“ pomenijo materiale in izdelke, ki so namenjeni podaljšanju roka uporabnosti ali vzdrževanju ali izboljšanju stanja pakiranih živil; zasnovani so, da namenoma vsebujejo sestavine, ki sprostijo snovi v pakirana živila ali jih absorbirajo iz pakiranih živilih ali okolja, ki živila obdaja;
‘intelligent materials and articles’ means materials and articles which monitor the condition of packaged food or the environment surrounding the food;
„inteligentni materiali in izdelki“ pomenijo materiale in izdelke, ki spremljajo stanje pakiranih živil ali okolja, ki živila obdaja;
‘component’ means an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into;
„sestavina“ pomeni posamezno snov ali kombinacijo posameznih snovi, ki povzročijo aktivno in/ali inteligentno delovanje materiala ali izdelka, vključno s proizvodi reakcije in situ navedenih snovi; ne zajemajo pasivnih delov, kot so materiali, ki so dodani ali vključeni;
‘functional barrier’ means a barrier consisting of one or more layers of food contact materials which ensures that the finished material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with this Regulation;
„funkcionalna pregrada“ pomeni pregrado, ki je sestavljena iz ene ali več plasti materiala za stik z živili, kar zagotavlja, da je končni material ali izdelek v skladu s členom 3 Uredbe (ES) št. 1935/2004 in to uredbo;
‘releasing active materials and articles’ are those active materials and articles designed to deliberately incorporate components that would release substances into or onto the packaged food or the environment surrounding the food;
„aktivni materiali in izdelki, ki sproščajo“ pomenijo tiste aktivne materiale in izdelke, ki so zasnovani, da namenoma vsebujejo sestavine, ki sprostijo snovi v ali na pakirana živila ali okolje, ki živila obdaja;
‘released active substances’ are those substances intended to be released from releasing active materials and articles into or onto the packaged food or the environment surrounding the food and fulfilling a purpose in the food.
„aktivne snovi, ki se sproščajo“ pomenijo tiste snovi, ki jih predvidoma sprostijo aktivni materiali in izdelki v ali na pakirana živila ali okolje, ki živila obdaja.
Placing on the market of active and intelligent materials and articles
Dajanje aktivnih in inteligentnih materialov in izdelkov na trg
Active and intelligent materials and articles may only be placed on the market if they:
Aktivni in inteligentni materiali in izdelki se lahko dajo na trg samo, če:
are suitable and effective for the intended purpose of use;
so ustrezni in učinkoviti za nameravano uporabo;
comply with the general requirements set out in Article 3 of Regulation (EC) No 1935/2004;
izpolnjujejo splošne zahteve iz člena 3 Uredbe (ES) št. 1935/2004;
comply with the special requirements set out in Article 4 of Regulation (EC) No 1935/2004;
izpolnjujejo posebne zahteve iz člena 4 Uredbe (ES) št. 1935/2004;
comply with the labelling requirements set out in Article 15(1)(e) of Regulation (EC) No 1935/2004;
izpolnjujejo zahteve glede označevanja iz člena 15(1)(e) Uredbe (ES) št. 1935/2004;
comply with the composition requirements set out in Chapter II of this Regulation;
izpolnjujejo zahteve o sestavi iz poglavja II te uredbe.
comply with labelling and declaration requirements set out in Chapters III and IV of this Regulation.
izpolnjujejo zahteve o označevanju in izjavi iz poglavij III in IV te uredbe.
Community list of authorised substances
Seznam Skupnosti za dovoljene snovi
Community list of substances that may be used in active and intelligent components
Seznam Skupnosti za snovi, ki se jih lahko uporablja v aktivnih in inteligentnih sestavinah
Only substances which are included in the ‘Community list’ of authorised substances (hereinafter referred to as the Community list) may be used in components of active and intelligent materials and articles.
Samo snovi, ki so vključene na seznam Skupnosti za dovoljene snovi (v nadaljnjem besedilu: seznam Skupnosti), se lahko uporabljajo v sestavinah aktivnih ali inteligentnih materialov ali izdelkov.
By way of derogation from paragraph 1, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list:
Z odstopanjem od odstavka 1 se lahko naslednje snovi, ne da bi bile vključene na seznam Skupnosti, uporabljajo v sestavinah aktivnih ali inteligentnih materialov ali izdelkov:
released active substances provided that they comply with the conditions set out in Article 9;
aktivne snovi, ki se sproščajo, če izpolnjujejo pogoje iz člena 9;
substances falling within the scope of Community or national provisions applicable to food, which are added to or incorporated into active materials and articles by techniques such as grafting or immobilisation in order to have a technological effect in the food, provided that they comply with the conditions set out in Article 9;
snovi, ki spadajo v področje uporabe predpisov Skupnosti ali nacionalnih predpisov, ki se uporabljajo za živila, ter se dodajajo ali vključujejo v aktivne materiale in izdelke s tehnikami, kot sta precepljanje ali imobilizacija, da imajo v živilih tehnološki učinek, če izpolnjujejo pogoje iz člena 9;
substances used in components which are not in direct contact with food or the environment surrounding the food and are separated from the food by a functional barrier provided that they comply with the conditions set out in Article 10 and that they do not fall within either of the following categories:
snovi, ki se uporabljajo v sestavinah, ki niso neposredno v stiku z živili ali z okoljem, ki jih obdaja, ter se od živil ločijo s funkcionalno pregrado, če izpolnjujejo pogoje iz člena 10 in ne spadajo v katero izmed 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 of the European Parliament and of the Council [5];
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 Evropskega parlamenta in Sveta [5];
substances deliberately engineered to particle size which exhibit functional physical and chemical properties that significantly differ from those at a larger scale.
snovi, namenoma ustvarjene v velikosti delcev, ki kažejo funkcionalne fizikalne in kemične lastnosti, ki so v veliki meri drugačne kot pri istih snoveh z večjimi delci.
Conditions for inclusion of substances in the Community list
Pogoji za uvrstitev snovi na seznam Skupnosti
In order to be included in the Community list, substances which constitute the components of active and intelligent materials and articles must satisfy the requirements of Article 3 and, where they apply, Article 4 of Regulation (EC) No 1935/2004 for the intended condition of use of the active or intelligent material or article.
Da se snovi, ki sestavljajo sestavine aktivnih in inteligentnih materialov in izdelkov, vključijo na seznam Skupnosti, morajo izpolnjevati zahteve iz člena 3 in, ko se uporablja, člena 4 Uredbe (ES) št. 1935/2004 v skladu s predvidenimi okoliščinami uporabe aktivnih ali inteligentnih materialov ali izdelkov.
Content of the Community list
Vsebina seznama Skupnosti
The Community list shall specify:
Na seznamu Skupnosti se opredelijo:
the identity of the substance(s);
identiteta snovi;
the function of the substance(s);
delovanje snovi;
the reference number;
referenčna številka;
if necessary, the conditions of use of the substance(s) or component;
če je potrebno, pogoji uporabe snovi ali sestavin;
if necessary, restrictions and/or specifications of use of the substance(s);
če je potrebno, omejitve in/ali specifikacije uporabe snovi;
if necessary, conditions of use of the material or article to which the substance or component is added or into which it is incorporated.
če je potrebno, pogoji uporabe materiala ali izdelka, kateremu je dodana snov ali sestavina ali v katerega je vključena.
Conditions for the establishment of the Community list
Pogoji za vzpostavitev seznama Skupnosti
The Community list shall be drawn up on the basis of applications made pursuant to Article 9 of Regulation (EC) No 1935/2004.
Seznam Skupnosti se oblikuje na podlagi vlog, ki se predložijo v skladu s členom 9 Uredbe (ES) št. 1935/2004.
The deadline for submitting applications shall be 18 months following the date of publication of the guidelines of the European Food Safety Authority (the Authority) for the safety assessment of substances used in active and intelligent materials and articles.
Rok za predložitev vlog je 18 mesecev po dnevu objave smernic Evropske agencije za varnost hrane (Agencija) za oceno varnosti snovi, ki se uporabljajo v aktivnih in inteligentnih materialih in izdelkih.
The Authority shall publish those guidelines at the latest six months after the date of publication of this Regulation.
Agencija objavi navedene smernice najpozneje šest mesecev po dnevu objave te uredbe.
The Commission shall make available to the public a register which contains all substances for which a valid application has been submitted in accordance with paragraph 2.
Komisija da javnosti na voljo register, ki zajema vse snovi, za katere je bila vložena veljavna vloga v skladu z odstavkom 2.
The Community list shall be adopted by the Commission in accordance with the procedure laid down in Articles 10 and 11 of Regulation (EC) No 1935/2004.
Komisija sprejme seznam Skupnosti v skladu s postopkom iz členov 10 in 11 Uredbe (ES) št. 1935/2004.
Where the Authority requests supplementary information and the applicant fails to provide the additional data within the set time limit, the substance shall not be evaluated by the Authority for inclusion in the Community list as the application cannot be considered a valid application.
Kadar Agencija zahteva dodatne informacije in vlagatelj ne zagotovi dodatnih podatkov v določenem roku, Agencija snovi ne bo ocenila za vključitev na seznam Skupnosti, saj se vloga ne more obravnavati kot veljavna.
The Commission shall adopt the Community list after the Authority has delivered its opinion on all substances included in the register for which a valid application has been submitted pursuant to paragraphs 2 and 5.
Komisija sprejme seznam Skupnosti po tem, ko Agencija da svoje mnenje o vseh snoveh, vključenih v register in za katere je bila vložena veljavna vloga v skladu z odstavkoma 2 in 5.
For the addition of new substances to the Community list, the procedure laid down in Articles 9, 10 and 11 of Regulation (EC) No 1935/2004 shall apply.
Za dodajanje novih snovi na seznam Skupnosti se uporablja postopek iz členov 9, 10 in 11 Uredbe (ES) št. 1935/2004.
Conditions of use for substances not to be included in the Community list
Pogoji uporabe snovi, ki se ne vključijo na seznam Skupnosti
Substances referred to in Article 5(2)(a) and (b)
Snovi iz člena 5(2)(a) in (b)