natgillin/translations-raw huggingface dataset:
This Annex applies to health claims related to the consumption of a food category, a food, or its constituents (including a nutrient or other substance, or a combination of nutrients/other substances), hereafter referred to as ‘food’.
Ta priloga se uporablja za zdravstvene trditve v zvezi z uživanjem kategorije živila, živila ali njegove sestavine (vključno s hranilom ali drugo snovjo oziroma kombinacijo hranil/drugih snovi), v nadaljevanju „živila“.
In cases where some of the data that are required as described in this Annex are omitted by the applicant, assuming that they do not apply to the application concerned, reasons shall be given for the absence of such data in the application.
Kadar vlagatelj ne navede nekaterih podatkov, ki so zahtevani v skladu s to prilogo, ker meni, da se ne uporabljajo pri zadevni vlogi, navede razloge, zakaj v vlogi ni navedel teh podatkov.
The term ‘application’ hereafter means a stand-alone dossier containing the information and the scientific data submitted for authorisation of the health claim in question.
Pojem vloga v nadaljevanju pomeni samostojno dokumentacijo, ki vsebuje informacije in znanstvene podatke, ki se predložijo za odobritev zadevne zdravstvene trditve.
One application shall be prepared for each individual health claim; this means that only a relationship between a food and a single claimed effect can be the object of each application.
Vloga se pripravi za vsako posamično zdravstveno trditev; to pomeni, da se v vsaki vlogi obravnava le ena povezava med živilom in posamičnim navedenim učinkom.
However, multiple formulations of a food can be proposed by the applicant as candidates to bear the health claim in the same application, provided the scientific evidence is valid for all proposed formulations of a food bearing that same health claim.
Vendar lahko vlagatelj v isti vlogi predlaga, da se zdravstvena trditev uporabi za številne formulacije živila, če so znanstveni dokazi pozitivni za vse predlagane formulacije živila, na katerih bi bila ista zdravstvena trditev.
The application shall indicate whether health claim concerned or a similar one has been scientifically evaluated, by a competent national authority of either a Member State or a third country.
V vlogi se navede, ali je pristojni nacionalni organ države članice ali tretje države znanstveno ocenil navedeno zdravstveno trditev ali podobno zdravstveno trditev.
If so, a copy of the scientific evaluation shall be provided.
Če je, potem je treba predložiti kopijo znanstvene ocene.
Pertinent scientific data are all human and non-human studies, published or unpublished, that are relevant for the substantiation of health claim applied for, by addressing the relationship between the food and the claimed effect, including data in favour and data not in favour of such relationship.
Ustrezni znanstveni podatki so vse humane študije ali nehumane študije, objavljene ali neobjavljene, ki so ustrezne za utemeljitev zdravstvene trditve, za katero se vloži vloga, in ki obravnavajo razmerje med živilom in navedenim učinkom, vključno s podatki, ki podpirajo, in podatki, ki zavračajo takšno povezavo.
Pertinent published human data shall be identified through a comprehensive review.
Ustrezni objavljeni podatki, pridobljeni s humanimi študijami, se opredelijo z natančnim pregledom.
Journal abstracts and articles published in newspapers, magazines, newsletters or handouts that have not been peer-reviewed shall not be cited.
Povzetki iz strokovnih revij ter članki, objavljeni v časopisih, publicističnih revijah, glasilih ali izročkih, ki niso bili strokovno pregledani, se ne navedejo.
Books or chapters of books for consumers or the general public shall not be cited.
Knjige ali poglavja knjig za potrošnike ali širšo javnost se ne navedejo.
GENERAL PRINCIPLES FOR THE SCIENTIFIC SUBSTANTIATION
SPLOŠNA NAČELA ZA ZNANSTVENO UTEMELJITEV
The application shall contain all scientific data, published and unpublished, in favour and not in favour that are pertinent to the health claim, together with a comprehensive review of the data from human studies in order to demonstrate that the health claim is substantiated by the totality of the scientific data and by weighing the evidence.
V vlogi se navedejo vsi znanstveni podatki, objavljeni in neobjavljeni, ki podpirajo ali zavračajo zdravstveno trditev in so ustrezni, ter natančen pregled podatkov iz humanih študij, da se pokaže, da je zdravstvena trditev utemeljena z vsemi znanstvenimi podatki in tehtnimi dokazi.
Data from studies in humans addressing the relationship between consumption of the food and the claimed effect is required for substantiation of a health claim.
Podatke iz humanih študij, ki obravnavajo povezavo med uživanjem živila in navedenim učinkom, je treba navesti za utemeljitev zdravstvene trditve.
The application shall contain a comprehensive review of the data from human studies addressing the specific relationship between the food and the claimed effect.
Vloga vsebuje natančen pregled podatkov iz humanih študij, ki obravnavajo posebno povezavo med živilom in navedenim učinkom.
This review, and the identification of data considered pertinent to the health claim, should be performed in a systematic and transparent manner in order to demonstrate that the application reflects adequately the balance of all the evidence available.
Ta pregled in opredelitev podatkov, ki se obravnavajo kot ustrezni za zdravstveno trditev, je treba opraviti na sistematičen in pregleden način, da se pokaže, da so v vlogi enakomerno zastopani vsi razpoložljivi podatki.
The substantiation of health claims shall take into account the totality of the available scientific data and, by weighing the evidence, shall demonstrate the extent to which:
Pri utemeljitvi zdravstvene trditve se upoštevajo vsi razpoložljivi znanstveni dokazi in tehtnost dokazov, da se pokaže, da:
the claimed effect of the food is beneficial for human health;
navedeni učinek živila dobrodejno vpliva na zdravje ljudi;
a cause and effect relationship is established between consumption of the food and the claimed effect in humans (such as the strength, consistency, specificity, dose-response, and biological plausibility of the relationship);
med uživanjem živila in navedenim učinkom pri ljudeh obstaja vzročno-posledična povezava (kot je: moč, doslednost, specifičnost, odziv glede na odmerek ter biološka verjetnost povezave);
the quantity of the food and pattern of consumption required to obtain the claimed effect could reasonably be achieved as part of a balanced diet;
se lahko količina živila in vzorec uživanja, ki sta potrebna za navedeni učinek, dosežeta v okviru uravnotežene prehrane;
the specific study group(s) in which the evidence was obtained is representative of the target population for which the claim is intended.
so skupine, vključene v raziskavo za potrditev dokazov, reprezentativne glede na ciljno populacijo, kateri je trditev namenjena.
FOOD CHARACTERISTICS
ZNAČILNOSTI ŽIVILA
The following information shall be given with regard to the food constituent, the food or the food category for which the health claim is made.
Za sestavino živila, živilo ali kategorijo živila, za katere se uporablja zdravstvena trditev, se predložijo naslednje informacije:
For a food constituent:
Za sestavino živila:
the source and specifications [1], such as physical and chemical properties, composition; and
izvor in specifikacije [1], kot so fizikalne in kemijske lastnosti, sestava, ter
where applicable, the microbiological constituents of the food constituent.
po potrebi mikrobiološka sestava sestavine živila.
For a food or category of food:
Za živilo ali kategorijo živila:
the description of the food or food category, including characterisation of the food matrix and the overall composition including the nutrient content of the food;
opis živila ali kategorije živila, vključno z značilnostmi oblike živila in celotno sestavo, vključno z vsebnostjo hranil v živilu;
the source and specifications of the food or food category and, in particular, the content of the constituent(s) related to the health claim.
izvor in specifikacije živila ali kategorije živila ter zlasti vsebnost sestavin živila, ki so v povezavi z zdravstveno trditvijo.
In all cases:
V vseh primerih:
where applicable, the variability from batch to batch;
morebitna odstopanja od šarže do šarže, kjer do njih prihaja;
analytical methods applied;
uporabljene analizne metode;
where applicable, a summary of the studies undertaken on production conditions, batch-to-batch variability, analytical procedures, and of the results and conclusions of the stability studies, and the conclusions with respect to storage conditions and shelf-life;
po potrebi povzetek študij o pogojih proizvodnje, odstopanja od serije do serije, analiznih postopkih ter povzetek rezultatov in sklepov študij stabilnosti ter sklepi glede pogojev shranjevanja in roka uporabnosti;
where applicable, the relevant data and rationale that the constituent for which the health claim is made is in a form that is available to be used by the human body;
po potrebi ustrezni podatki in dokaz, da je sestavina živila, za katero se uporablja zdravstvena trditev, v obliki, ki jo človeški organizem lahko izkoristi;
if absorption is not necessary to produce the claimed effect, such as for plant sterols, fibres, lactic acid bacteria, the relevant data and rationale that the constituent reaches the target site;
ustrezni podatki in dokazi, da je sestavina živila izkoristljiva, če za navedeni učinek ni potrebna absorpcija, kot je pri rastlinskih sterolih, vlakninah in mlečnokislinskih bakterijah;
all available data on factors that could affect the absorption or utilisation in the body of the constituent for which the health claim is made.
vsi razpoložljivi podatki o dejavnikih, ki bi lahko vplivali na absorpcijo ali delovanje sestavine živila v telesu, za katero se uporablja zdravstvena trditev.
ORGANISATION OF PERTINENT SCIENTIFIC DATA
ORGANIZACIJA USTREZNIH ZNANSTVENIH PODATKOV
Scientific data identified shall be organised in the following order: human data, followed by non-human data if appropriate.
Opredeljene znanstvene podatke se organizira po naslednjem vrstnem redu: podatkom, pridobljenim s humanimi študijami, sledijo po potrebi podatki, pridobljeni z nehumanimi študijami.
Human data shall be classified according to a hierarchy of study design in the following order:
Podatki, pridobljeni s humanimi študijami, se razvrstijo v skladu s hierarhijo zasnove študij po naslednjem vrstnem redu:
human intervention studies, randomised controlled studies, other randomised studies (non-controlled), controlled (non-randomised) studies, other intervention studies;
humane intervencijske študije, randomizirane kontrolne študije, druge randomizirane študije (nekontrolne), kontrolne (nerandomizirane) študije, druge humane intervencijske študije;
human observational studies, cohort studies, case-control studies, cross-sectional studies, other observational studies, such as case reports;
humane opazovalne študije, kohortne študije, študije primerov in kontrole, (case-control studies), presečne študije, druge opazovalne študije, kot je poročanje o primerih;
other human studies dealing with the mechanisms by which the food could be responsible for the claimed effect, including the studies on bioavailability.
druge humane študije, ki obravnavajo mehanizme, zaradi katerih bi živilo lahko imelo navedeni učinek, vključno s študijami o biološki razpoložljivosti.
Non-human data shall consist in:
Podatki, pridobljeni z nehumanimi študijami, obsegajo:
animal data including studies investigating aspects related to absorption, distribution, metabolism, excretion of the food, mechanistic studies, and other studies;
podatke o živalih, vključno s študijami, ki obravnavajo vidike v zvezi z absorpcijo, razporeditvijo, presnovo, izločanjem živila, ter študijami mehanizmov in drugimi študijami;
ex vivo or in vitro data, based on either human or animal biological samples related to the mechanisms of action by which the food could be responsible for the claimed effect, and other non-human studies.
podatke, pridobljene na poskusih ex vivo ali in vitro na človeških ali živalskih bioloških vzorcih, v zvezi z mehanizmi delovanja, zaradi katerih bi živilo lahko imelo navedeni učinek, ter iz drugih nehumanih študij.
SUMMARY OF PERTINENT SCIENTIFIC DATA
POVZETEK USTREZNIH ZNANSTVENIH PODATKOV
In addition to the requirement of Article 15(3)(g) of Regulation (EC) No 1924/2006 for a summary of the application, applicants shall provide a summary of the pertinent scientific data, which shall contain the following information:
Vlagatelj poleg povzetka vloge v skladu s členom 15(3)(g) Uredbe (ES) št. 1924/2006 predloži povzetek ustreznih znanstvenih podatkov, ki vsebujejo naslednje informacije:
the summary of data from pertinent human studies, indicating to what extent the relationship between the food and the claimed effect is supported by the totality of human data;
povzetek podatkov iz ustreznih humanih študij, ki pojasnjuje, v kakšni meri podpirajo vsi podatki, pridobljeni s humanimi študijami, povezavo med živilom in navedenim učinkom;
the summary of data from pertinent non-human studies, indicating how, and to what extent, the pertinent non-human studies may help to support the relationship between the food and the claimed effect in humans;
povzetek podatkov iz ustreznih nehumanih študij, ki pojasnjuje, kako in v kakšni meri lahko ustrezne nehumane študije prispevajo k potrditvi povezave med živilom in navedenim učinkom pri ljudeh;
the overall conclusions, by taking into account the totality of the data, including evidence in favour and not in favour and by weighing the evidence.
splošne sklepe ob upoštevanju vseh podatkov, vključno z dokazi, ki podpirajo, in dokazi, ki zavračajo povezavo, ter tehtnosti dokazov.
The overall conclusions should clearly define to what extent:
Splošni sklepi morajo jasno opredeliti, v kakšni meri:
a cause and effect relationship is established between the consumption of the food and the claimed effect in humans (such as the strength, consistency, specificity, dose-response, and biological plausibility of the relationship);
je med uživanjem živila in navedenim učinkom pri ljudeh vzročno-posledična povezava (kot je: moč, doslednost, specifičnost, odziv glede na odmerek ter biološka verjetnost povezave);
the quantity of the food and pattern of consumption required to obtain the claimed effect could reasonably be consumed as part of a balanced diet;
se lahko količina živila in vzorec uživanja, ki sta potrebna za navedeni učinek, dosežeta v okviru uravnotežene prehrane;
STRUCTURE OF THE APPLICATION
SESTAVA VLOGE
Applications shall be structured as follows.
Vloga se sestavi na naslednji način.
If justification is provided by the applicant certain parts can be omitted.
Vlagatelj lahko izpusti nekatere dele, če to utemelji.
Part 1 — Administrative and Technical Data
Del 1 – Upravni in tehnični podatki
Application form
Obrazec vloge
Health claim particulars
Podatki o zdravstveni trditvi
Summary of the application
Povzetek vloge
Part 2 — Food/Constituent Characteristics
Del 2 – Značilnosti živila/sestavine živila
Food constituent
Sestavina živila
Food or category of food
Živilo ali kategorija živila
Part 3 — Overall Summary of Pertinent Scientific Data
Del 3 – Splošni povzetek ustreznih znanstvenih podatkov
Tabulated summary of all pertinent studies identified
Povzetek vseh opredeljenih ustreznih študij, prikazan v obliki preglednic
Tabulated summary of data from pertinent human studies
Povzetek podatkov iz ustreznih humanih študij, prikazan v obliki preglednic
Written summary of data from pertinent human studies
Pisni povzetek podatkov iz ustreznih humanih študij
Written summary of data from pertinent non-human studies
Pisni povzetek podatkov iz ustreznih nehumanih študij
Overall conclusions
Splošni sklepi
Part 4 — Body of Pertinent Scientific Data Identified
Del 4 – Jedro opredeljenih ustreznih znanstvenih podatkov
Identification of pertinent scientific data
Opredelitev ustreznih znanstvenih podatkov
Pertinent data identified
Opredelitev ustreznih podatkov
Part 5 — Annexes to the Application
Del 5 – Priloge k vlogi
Glossary/abbreviations
Glosar/kratice
Copies/reprints of pertinent published data
Kopije/ponatisi ustreznih objavljenih podatkov
Full study reports of pertinent unpublished data
Celotna poročila ustreznih neobjavljenih podatkov
Where appropriate internationally recognised specifications may be cited.
Kjer je primerno, se lahko navedejo mednarodno priznane specifikacije.
Commission Regulation (EC) No 354/2008
Uredba Komisije (ES) št. 354/2008
This Regulation shall enter into force on 22 April 2008.
Ta uredba začne veljati 22. aprila 2008.
to Commission Regulation of 21 April 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables
k Uredbi Komisije z dne 21. aprila 2008 o določitvi pavšalnih uvoznih vrednosti za določanje vhodne cene nekaterega sadja in zelenjave
Commission Regulation (EC) No 355/2008
Uredba Komisije (ES) št. 355/2008
amending Regulation (EC) No 1239/95 as regards the use of electronic means of communication in proceedings before the Community Plant Variety Office
o spremembi Uredbe (ES) št. 1239/95 v zvezi z uporabo elektronskih komunikacijskih sredstev v postopkih, ki potekajo na Uradu Skupnosti za rastlinske sorte
Having regard to Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights [1], and in particular Article 114 thereof,
ob upoštevanju Uredbe Sveta (ES) št. 2100/94 z dne 27. julija 1994 o žlahtniteljskih pravicah v Skupnosti [1] in zlasti člena 114 Uredbe,
The rules provided for in Commission Regulation (EC) No 1239/95 of 31 May 1995 establishing implementing rules for the application of Council Regulation (EC) No 2100/94 as regards proceedings before the Community Plant Variety Office [2] should be simplified, in particular by allowing the use of electronic means of communication.
Pravila iz Uredbe Komisije (ES) št. 1239/95 z dne 31. maja 1995 o uvedbi izvedbenih pravil za izvajanje Uredbe Sveta (ES) št. 2100/94 v zvezi s postopki, ki potekajo na Uradu Skupnosti za rastlinske sorte [2], je treba poenostaviti, zlasti z omogočanjem uporabe elektronskih komunikacijskih sredstev.
It is appropriate to simplify, on the one hand, the filing of applications, objections or appeals and, on the other, the service of documents by the Community Plant Variety Office (the Office) by permitting the use of electronic means.
Po eni strani je primerno poenostaviti vložitve prijav, ugovorov ali pritožb, in po drugi strani vročitve dokumentov Urada Skupnosti za rastlinske sorte (v nadaljnjem besedilu „urad“) z omogočanjem uporabe elektronskih komunikacijskih sredstev.
Moreover, the Office should be given the possibility to issue certificates for Community plant variety rights in electronic form.
Poleg tega je treba uradu omogočiti izdajo spričeval žlahtniteljskih pravic v Skupnosti v elektronski obliki.
Publication of information regarding Community plant variety rights should also be possible by electronic means.
Treba je tudi omogočiti elektronsko objavo informacij glede žlahtniteljskih pravic v Skupnosti.
Finally, electronic storage of files relating to proceedings should be allowed to improve efficiency.
Prav tako je treba z elektronskim shranjevanjem datotek v zvezi s postopki izboljšati učinkovitost.
The President of the Office should be empowered to determine all necessary details with respect to the use of electronic means of communication or storage.
Predsednika urada je treba pooblastiti, da določi vse potrebne podrobnosti glede uporabe elektronskih komunikacijskih sredstev ali sredstev shranjevanja.
Regulation (EC) No 1239/95 should therefore be amended accordingly.
Uredbo (ES) št. 1239/95 je zato treba ustrezno spremeniti.
Addresses shall contain all the relevant administrative information, including the name of the State in which the party to proceedings is resident or where his seat or establishment is located.
Naslovi vsebujejo vse ustrezne upravne informacije, vključno z imenom države, kjer ima stranka v postopku stalno bivališče, sedež ali podjetje.
Only one address should preferably be indicated for each party to proceedings; where several addresses are indicated, only the address mentioned first shall be taken into account, except where the party to proceedings designates one of the other addresses as an address for service.
Priporoča se samo en naslov za vsako stranko v postopku; kadar je navedenih več naslovov, se upošteva samo prvi omenjeni naslov, razen kadar stranka v postopku navede enega od drugih naslovov kot svoj službeni naslov.
The President of the Office shall determine the details concerning the address including any relevant details of other data communication links.’;
Predsednik urada določi podrobnosti v zvezi z naslovom, vključno z vsemi ustreznimi podrobnostmi drugih komunikacijskih povezav.“
An application for a Community plant variety right shall be filed at the Office, at the national agencies designated or the sub-offices established pursuant to Article 30(4) of the Basic Regulation.
Prijava za žlahtniteljsko pravico v Skupnosti se vloži pri uradu ali pri določenih nacionalnih agencijah ali poduradih, ki so ustanovljeni v skladu s členom 30(4) osnovne uredbe.
Where the application is filed at the Office it may be filed in paper format or by electronic means.
Kadar se prijava vloži pri uradu, se lahko izpolni na papirju ali elektronsko.
Where it is filed at the national agencies or sub-offices it shall be filed in paper format in duplicate.’;
Kadar se vloži pri nacionalnih agencijah ali poduradih, se izpolni na papirju v dveh izvodih.“;
The Office shall make available the following forms free of charge:
Urad zagotovi naslednje brezplačne obrazce:
an application form and a technical questionnaire, for the purposes of filing an application for a Community plant variety right;
obrazec prijave in tehnični vprašalnik, ki sta namenjena vložitvi prijave za žlahtniteljsko pravico v Skupnosti;
a form for forwarding the information referred to in paragraph 2, indicating the consequences of any failure of the forwarding.
obrazec za pošiljanje informacij iz odstavka 2, v katerem so navedene posledice v primeru, če informacije niso poslane.
The applicant shall fill in and sign the forms provided for in paragraph 3.
Obrazce iz odstavka 3 izpolni in podpiše prijavitelj.
Where the application is submitted by electronic means it shall comply with the second subparagraph of Article 57(3) as regards the signature.’;
Kadar se prijava predloži elektronsko, se podpiše v skladu z drugim pododstavkom člena 57(3).“
Article 28 is replaced by the following:
Člen 28 se nadomesti z naslednjim:
Proposal for a variety denomination
Predlog imena sorte
The proposal for a variety denomination shall be signed and shall be filed at the Office, or, if the proposal accompanies the application for a Community plant variety right filed at the national agency designated or the sub-office established pursuant to Article 30(4) of the Basic Regulation, in duplicate.
Predlog imena sorte se podpiše in vloži na uradu ali v dveh izvodih, če je predlog priložen v prijavi za žlahtniteljsko pravico v Skupnosti, vloženo pri določeni nacionalni agenciji ali poduradu, ustanovljenim v skladu s členom 30(4) osnovne uredbe.
The Office shall make available, free of charge, a form for the purposes of proposing a variety denomination.
Obrazec za predlog imena sorte urad zagotovi brezplačno.
Where the proposal for a variety denomination is submitted by electronic means it shall comply with the second subparagraph of Article 57(3) as regards the signature.’;
Kadar se predlog za imena sorte predloži elektronsko, se podpiše v skladu z drugim pododstavkom člena 57(3).“
in Article 36, the last sentence of paragraph 1 is deleted and the following paragraph 4 is added:
V členu 36 se črta zadnji stavek odstavka 1, doda pa se naslednji odstavek 4:
Where the proposal for an amendment of a variety denomination is submitted by electronic means it shall comply with the second subparagraph of Article 57(3) as regards the signature.’;
Kadar se predlog za spremembo imena sorte predloži elektronsko, se podpiše v skladu z drugim pododstavkom člena 57(3).“