natgillin/translations-raw huggingface dataset:
c) priporočeno formulacijo predlagane zdravstvene trditve, v vseh jezikih Skupnosti;
(c) the recommended wording, in all Community languages, of the proposed health claim;
d) po potrebi pogoje za uporabo živila in/ali dodatna pojasnila ali opozorila, ki naj bi spremljala zdravstveno trditev na etiketi ali pri oglaševanju.
(d) where necessary, conditions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and advertising.
Upravni organ posreduje svoje mnenje, vključno s poročilom o oceni zdravstvene trditve in z utemeljitvijo za svoje mnenje, Komisiji, državam članicam in vlagatelju.
The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion.
Upravni organ da svoje mnenje na razpolago javnosti v skladu z odstavkom 1 člena 38 Uredbe (ES) št 178/2002.
The Authority in accordance with Article 38(1) of Regulation (EC) No 178/2002 shall make its opinion public.
Člen 15, odstavek 3, točka (a)
Article 15, paragraph 3, point (a)
(a) da je predlagana ubeseditev zdravstvene trditve podprta z znanstvenimi podatki;
(a) that the proposed wording of the health claim is substantiated by scientific data ;
(a) da je predlagana ubeseditev zdravstvene trditve znanstveno podprta ;
(a) that the proposed wording of the health claim is substantiated scientifically ;
Znanstvena spoznanja namesto podatkov morda niso dovolj za utemeljitev predlagane ubeseditve zdravstvenih trditev.
Scientific knowledge rather than data may be sufficient to substantiate the proposed wording of the health claim.
Člen 15, odstavek4, točka (c)
Article 15, paragraph 4, point (c)
(c) priporočena ubeseditev v vseh jezikih Skupnosti za predlagane zdravstvene trditve;
(c) the recommended wording, in all Community languages , of the proposed health claim;
(c) priporočena ubeseditev v jezikih Skupnosti, v katerih bodo zapisani predlagane zdravstvene trditve;
(c) a proposal for the recommended wording, in the languages in which the proposed health claim will be made ;
Znanstvena podlaga in pomen trditev mora biti zajet v predhodno odobritev, vendar je zelo pomembno, da se proizvajalcem, omogoči, kot prilagodljiv ukrep, prenos sporočil o zdravem prehranjevanju in zdravju, ki so namenjena potrošnikom.
The scientific basis and the meaning of a claim can and must be covered by prior authorisation, but it is very important to allow manufacturers a measure of flexibility when they impart messages about diet and health aimed at consumers.
Urad bo vseeno sestavil predlog smernic.
The Authority should, however, produce a proposal for guidance.
Obveznost ubeseditve predloga v vseh jezikih Skupnosti je oviralna in nepotrebna, če trditev ne bo uporabljena v vseh jezikih.
The obligation to word the proposal in all Community languages is cumbersome and unnecessary when the claim will not be used in all languages.
Komisija predloži v roku treh mesecev po prejemu mnenja upravnega organa odboru osnutek odločbe o vlogi v skladu z odstavkom člena 23, pri čemer se upošteva mnenje upravnega organa, vse zadevne določbe prava Skupnosti in druge dejavnike, ki so pomembni in legitimni za vsako preverjanje dejanskega stanja.
Within three months of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(1) a draft of the decision to be taken in respect of the application, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration.
Če se osnutek odločbe ne ujema z mnenjem upravnega organa, pojasni Komisija razloge za odstopanje.
Where the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
Vsak osnutek odločbe, ki predvideva izdajo dovoljenja, vsebuje podatke, ki so navedeni v odstavku 4 člena 15, in ime imetnika dovoljenja.
Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 15(4) and the name of the authorisation-holder.
Dokončna odločba o vlogi se sprejme po postopku in odstavka 2 člena 23.
A final decision on the application shall be adopted in accordance with the procedure referred to in Article 23(2).
Komisija nemudoma obvesti vlagatelja o svoji odločbi, podrobnosti te odločbe pa objavi v Uradnem listu Evropske unije.
The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.
Imetnik dovoljenja lahko zaprosi za spremembo obstoječega dovoljenja v skladu s postopkom iz člena 14.
The authorisation-holder may, in accordance with the procedure laid down in Article 14, apply for a modification of an existing authorisation.
Upravni organ predloži na lastno pobudo ali na predlog države članice mnenje o tem, ali je odločba v zvezi z uporabo zdravstvene trditve, še vedno v skladu s pogoji te uredbe.
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a decision for the use of a health claim continues to meet the conditions laid down in this Regulation.
Upravni organ nemudoma posreduje svoje izvedensko mnenje Komisiji, upravičencu odobritve in državam.
It shall forthwith transmit its opinion to the Commission, the authorisation–holder and the Member States.
Upravni organ da svoje mnenje na razpolago javnosti v skladu z odstavkom 1 člena 38 Uredbe (ES) št 178/2002.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Javnost lahko v zvezi s tem v roku 30 dni po objavi Komisije posreduje svoja stališča.
The public may submit comments to the Commission within 30 days of such publication.
Komisija nemudoma preveri mnenje upravnega organa.
The Commission shall examine the opinion of the Authority as soon as possible.
Register Skupnosti
Community Register
Komisija izdela in vzdržuje register Skupnosti v zvezi s prehranskimi navedbami in zdravstvenimi trditvami na živilih, v nadaljevanju „register“.
The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as 'the Register'.
a) prehranske navedbe in pogoje za njihovo uporabo v skladu s Prilogo;
(a) the nutrition claims and the conditions applying to them as set out in the Annex;
b) odobrene zdravstvene trditve in pogoje za njihovo uporabo v skladu z odstavkom 2 člena 13, odstavkom 2 člena 17, odstavkoma 1 in 2 člena 19, odstavkom 2 člena 21 in odstavkom 2 člena 22;
(b) the authorised health claims and the conditions applying to them provided for in Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2);
c) seznam neodobrenih zdravstvenih trditev.
(c) a list of rejected health claims.
Zdravstvene trditve, ki so bili odobrene na podlagi zaupnih podatkov, se vpišejo v poseben dodatek registra z naslednjimi informacijami:
Health claims authorised on the basis of proprietary data shall be placed on a separate Annex to the Register with the following information:
(1) datum dovoljenja za zdravstveno trditev s strani Komisije in ime prvotnega vlagatelja, ki mu je bilo izdano dovoljenje;
(1) the date the Commission authorised the health claim and the name of the original a p plicant that was granted authorisation;
(3) opozorilo o tem, da je uporaba zdravstvene trditve omejena, razen če kasnejši vlagatelj pridobi dovoljenje za trditev brez sklica na zaupne podatke prvotnega vlagatelja.
(3) that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original a p plicant.
Znanstveni podatki in druge informacije, ki jih vsebuje dokumentacija vlagatelja, zahtevana v skladu z odstavkom 2 člena 14, se v roku sedmih let od datuma dovoljenja ne smejo uporabiti v prid poznejšega vlagatelja, razen če se je poznejši vlagatelj dogovoril s prejšnjim vlagateljem, da se lahko takšni podatki in informacije uporabijo, ob predpostavki, da:
The scientific data and other information in the application dossier required under Article 14 (2) may not be used for the benefit of a subsequent applicant for a period of seven years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
a) so bili znanstveni podatki in druge informacije s strani prvotnega vlagatelja v času prvotne vloge izrečeni za zaupne; in
(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and,
b) je imel prvotni vlagatelj v času prvotne vloge izključno pravico do uporabe zaupnih podatkov; in
(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior applic a tion was made; and,
c) zdravstvena trditev ne bi mogla biti odobrena brez predložitve zaupnih podatkov s strani prvotnega vlagatelja.
(c) the health claim could not have been approved without the submission of the proprietary data by the prior applicant.
Člen 19 a
Article 19 a
Predložitev vloge za odobritev trditev ali registracija objave takih trditev ne posega v pravice intelektualne lastnine, ki jih lahko ima vlagatelj v zvezi s samo trditvijo ali katerim koli znanstvenim podatkom ali zadevnim podatkom iz dokumentacije, ki spremlja vlogo.
The submission of an application for approval of a claim, or the registration or publication of such a claim, shall be without prejudice to any intellectual property rights which the applicant may enjoy in relation to the claim itself, or to any scientific data or any information contained in the application dossier.
Take pravice se obravnavajo v skladu s pravnim redom Skupnosti ali v skladu z nacionalnimi določbami, ki niso v nasprotju s pravnim redom skupnosti.
Such rights shall be treated in accordance with Community law, or with any national provisions which do not conflict with Community law.
Zaščitni ukrepi
Safeguard measures
Če ima država članica resne pomisleke, da se zahteva ne ujema s to uredbo ali da je znanstvena utemeljitev iz člena 7 pomanjkljiva, država članica lahko začasno ustavi uporabo te zahteve na njenem ozemlju.
Where a Member State has serious grounds for considering that a claim does not comply with this Regulation, or that the scientific substantiation provided for in Article 7 is insufficient, that Member State may temporarily suspend the use of that claim within its territory.
O tem obvesti druge države članice in Komisijo ter navede vzroke za opustitev.
It shall inform the other Member States and the Commission and give reasons for the suspension.
V skladu s postopkom iz člena 23(2) se sprejme odločba, kadar je to primerno, po pridobitvi mnenja Urada.
In accordance with the procedure referred to in Article 23(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
Komisija lahko začne postopek na lastno pobudo.
The Commission may initiate this procedure on its own initiative.
Država članica iz odstavka 1 lahko ohranja opustitev, dokler ji ni sporočena odločitev iz člena 2.
The Member State referred to in paragraph 1 may maintain the suspension until the decision referred to in paragraph 2 has been notified to it.
Določba, ki omogoča „začasno opustitev“ za trditve, ki niso v skladu z uredbo, ali za trditve, kjer se znanstvena utemeljitev pokaže za negotovo, krši člen 28 Pogodbe ES (načelo prostega pretoka blaga).
A provision permitting the 'temporary suspension' of claims which do not comply with the regulation or of those where the scientific substantiation appears uncertain infringes Article 28 of the EC Treaty (principle of the free movement of goods).
Zaradi zmanjšanja neoviranega prostega pretoka blaga na notranjem evropskem trgu se člen 22 izbriše.
Against the backdrop of the untrammelled free movement of goods in the European internal market Article 22 should be deleted.
Če je nemogoče izbrisati ta člen, ima zgoraj omenjena pravica države članice smisel le v primeru zahtev v skladu s členom 12(3), ker so druge zahteve odobrene s strani Evropskega urada za varno hrano in so zato v skladu z uredbo.
Should it be impossible to delete it, the Member States' right referred to above only makes sense in the case of claims pursuant to Article 12(3), since the other claims are permitted by the EFSA and thus comply with the regulation.
Poleg tega je ukrep, ki ga sprejme država članica, upravičen le v primeru, kadar dejansko tveganje za zdravje temelji na zavajajoči zahtevi.
In addition, a measure adopted by a Member State would be justified only in a case where a misleading claim might be the basis for an actual health risk .
Člen 22 je torej treba spremeniti tako, kot je nakazano v Predlogu spremembe 112.
Article 22 would therefore have to be amended as indicated in Amendment 112.
Člen 24
Article 24
Da bi olajšali učinkovito spremljanje živil s hranilno vrednostjo ali zdravjem, lahko države članice od proizvajalca ali osebe, ki daje takšna živila na trg na njihovem ozemlju, zahtevajo, da s posredovanjem vzorca oznake tega izdelka o tem obvesti pristojne organe.
To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.
Organi spremljajo oglaševanje živil vključno s prehranskimi navedbami in zdravstvenimi trditvami, da v skladu z Direktivo 2000/13/ES preprečijo zavajanje potrošnika z danimi podatki.
The Authority will monitor advertising campaigns for foods including nutrition and health claims to ensure that, in line with Directive 2000/13/EC, the consumer is not misled by the information provided.
Oglaševalske kampanje/logotipi/oglaševanje izdelkov s športniki igra pomembno vlogo pri zaznavanju hranilnih vrednosti in zdravja s strani potrošnika.
The advertising campaigns/logos/product endorsements by sportspersons play an important role in the way nutrition and health claims are perceived by the consumer.
V Združenih državah Amerike veljavnost oglaševanja živil spremlja Zvezna komisija za trgovino in podobno bi moralo prevladati tudi na ravni EU, kjer bi Evropskemu uradu za varno hrano dovolili spremljati in izražati mnenje v posebnih primerih, kadar oglaševanje zavaja in ne obvešča potrošnika.
In the United States the validity of food advertising campaigns is monitored by the Federal Trade Commission and a similar situation should prevail at EU level, with the EFSA being permitted to monitor and comment upon particular cases where advertising misleads rather than informs the consumer.
Prehodni ukrepi
Transitional measures
Zahteve za živila z visoko energijsko porabo, ki so bila proizvedena v skladu z nacionalnimi določili pred datumom veljavnosti, določenim v členu 26, se lahko še naprej proizvajajo do sprejetja Direktive Komisije o živilih, namenjenih športnikom in osebam z visoko energijsko porabo, ki temelji na Direktivi 89/398/EGS o živilih za posebne prehranske namene. .
Claims for foods for intense muscular effort which have been made in compliance with national provisions before the date of entry into force laid down in Article 26 may continue to be made until the adoption of a Commission directive on foods intended to meet the expenditure of intense muscular effort, especially for sports people, based on Directive 89/398/EEC on foods intended for particular nutritional uses.
Komisija se trenutno ukvarja z direktivo Komisije o živilih z visoko energijsko porabo, v okviru direktive o živilih za posebne prehranske namene (Direktiva 89/398/EGS).
The Commission is currently working on a Commission directive on foods for intense muscular effort, under the framework directive on foods for particular nutritional uses (Directive 89/398/EEC).
Prihodnja direktiva bo pojasnila potrebe po zahtevah v športni prehrani.
This upcoming directive will clarify the requirements for claims in sports foods.
Te zahteve so za izdelke, ki jih uporabljajo športniki, posebne in zato posebna direktiva omogoča določitev ustreznih meril za zahteve.
These claims are very specific to products used by athletes and therefore the specific directive enables the appropriate claims criteria to be defined.
Zaradi tega je v tej uredbi ustrezno predvideti prehodne ukrepe, dokler se ne sprejme ustrezna direktiva.
For this reason, it is appropriate to foresee transitional measures in this regulation until the appropriate directive has been adopted.
Člen 26, odstavek2
Article 26, paragraph 2
Uporablja se od [ prvega dne šestega meseca po objavi ].
It shall apply from [ first day of the sixth month following publication ].
Uporablja se od [ prvega dne osemnajstega meseca po objavi ].
It shall apply from [ first day of the eighteenth month following publication ]
Prehodno obdobje traja 18 mesecev, da se omogoči primeren čas, od objave uredbe do začetka njene uporabe, za sprejetje novih pravil določenih v uredbi.
To allow reasonable time to adapt to the new rules laid down in the regulation, the transitional period, from the time of publication of the regulation to the date on which it becomes applicable, should be 18 months.
Člen 26, odstavek3
Article 26, paragraph 3
Živila, dana na trg ali označena pred tem datumom , ki niso v skladu s to uredbo , se sme tržiti do [ zadnjega dne enajstega meseca po objavi ].
Foods placed on the market or labelled prior to that date which do not comply with this Regulation may be marketed until [ last day of the eleventh month following publication ].
Živila, dana na trg ali označena pred prvim dnem uporabe te uredbe, ki niso v skladu s to uredbo , se sme tržiti do [ zadnjega dne osemnajstega meseca po prvem dnevu njene uporabe ] ali do konca uporabnosti, odvisno od tega, katero obdobje je daljše.
Foods placed on the market or labelled prior to the first day of application of this Regulation which do not comply herewith may be marketed until [ last day of the eighteenth month following the first day of its application ] or until the end of their useful life, whichever period is the longer .
Prehodno obdobje ne zadostuje, ker objavljenih smernic Evropskega urada za varno hrano, postopka odobritve (najmanj 6 mesecev) ter sprememb označevanja in predstavitve verjetno ne bo mogoče zaključiti v času 11 mesecev, kot je določeno v predlogu Komisije, ki velja sedaj.
The transitional period may not be sufficient, since publication of the EFSA guidelines, the authorisation procedure (6 months at least), and the alterations to labelling and presentation might not be possible to complete within the 11 months specified in the Commission proposal as it now stands.
Člen 26, odstavek3 a (novo)
Article 26, paragraph 3 a (new)
Zdravstvene trditve, ki so različne od tistih iz člena 12(1), namenjene za živila, kategorije živil ali sestavine živil, se lahko še naprej določajo, pred veljavnostjo te uredbe v skladu z obstoječimi določili in pod pogojem, da se vloži zahtevek na podlagi člena 14 v roku 12 mesecev od veljavnosti te uredbe in šest mesecev pred končno odločitvijo, sprejeto na podlagi člena 16.
Health claims, other than those referred to in Article 12(1), that are made for foods, categories of foods or food constituents before this Regulation enters into force in compliance with existing provisions may continue to be made provided that an application is made pursuant to Article 14 within 12 months of the entry into force of this Regulation and before the expiry of a period of six months after a final decision is taken pursuant to Article 16.
Glede na takšne zahtevke časovni roki iz členov 15(1), 15(2) in 16(1) ne veljajo.
In respect of such applications, the time limits provided for in Articles 15(1), 15(2) and 16(1) shall not apply.
Potrebni so ustrezni prehodni sporazumi.
Adequate transition arrangements are necessary.
Od začetka veljavnosti uredbe, šest mesecev po objavi, se mora izdelke označevati v skladu z novo uredbo.
From the time the regulation applies, six months after publication, products need to be labelled in compliance with the new regulation.
Vendar bodo postopki, opisani v členih od 14 do 17 predloga Komisije, potrebovali precej več časa od šest mesecev.
However, the procedures outlined in Articles 14–17 of the Commission proposal will take significantly longer than six months.
Družbam se mora zato dovoliti nadaljevanje označevanja svojih izdelkov, ki so sedaj na trgu, do končne odločitve Evropskega urada za varno hrano in stalnega odbora, pod pogojem , da je zadevna družba vložila zahtevek za potrditev zahteve v skladu s postopkom odobritve.
Companies should therefore be permitted to continue to market their products which are currently on the market until a final decision by the EFSA and the Standing Committee, provided that the company in question has made an application for the claim to be approved according to the authorisation procedure.
Člen 26, odstavek 3 a (novo)
Article 26, paragraph 3 a (new)
Od začetka veljavnosti te uredbe iz prvega odstavka tega člena do sprejetja seznamov iz člena 12(2) so za zdravstvene trditve iz člena 12(1) odgovorna podjetja, pod pogojem, da so v skladu s to uredbo in z obstoječimi nacionalnimi določili, ki veljajo zanje, in brez poseganja v sprejetje zaščitnih ukrepov iz člena 22.
From the date of entry into force of this Regulation as referred to in paragraph 1 until the adoption of the lists referred to in Article 12(2), health claims as referred to in Article 12(1) may be made under the responsibility of business operators provided that they are in accordance with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of safeguard measures as referred to in Article 22.
Uredba mora družbam dovoliti nadaljevanje trženja svojih izdelkov, ki so sedaj na trgu, do končne odločitve Evropskega urada za varno hrano in stalnega odbora.
The regulation should allow companies to continue to market their products currently on the market until the EFSA and the Standing Committee have taken a final decision.
Člen 26, odstavek3 b (novo)
Article 26, paragraph 3 b (new)
Zdravstvene trditve, razen tistih iz člena 12(1), usklajene z obstoječimi določili v zvezi z živili, kategorijami živil ali hranili, se lahko v času veljavnosti te uredbe še naprej uporabljajo, pod pogojem, da se vloži zahtevek za dovoljenje v skladu s členom 14, v 12 mesecih od prvega dne veljavnosti te uredbe in do šest mesecev po končni odločitvi, sprejeti v skladu s členom 16.
Health claims other than those referred to in Article 12(1) made in accordance with existing provisions in respect of foods, categories of foods, or nutrients at the time of entry into force of this Regulation may continue to be made, provided that an application for authorisation in accordance with Article 14 is submitted within 12 months of the first day of application of this Regulation, during a period not exceeding six months after a final decision has been taken in accordance with Article 16.
Uredba mora družbam dovoliti nadaljevanje trženja svojih izdelkov, ki so sedaj na trgu, do končne odločitve Evropskega urada za varno hrano in stalnega odbora, pod pogojem, da je družba, za katero velja ta primer, vložila prošnjo za odobritev zahteve na podlagi postopka odobritve.
The regulation should allow companies to continue to market their products currently on the market until the EFSA and the Standing Committee have taken a final decision, provided that a company to which this case applies has submitted an application to enable its claim to be authorised under the authorisation procedure.
Zgornja prehodna določba bi bila v korist vsem zadevnim strankam, vključno z organi, pristojnimi za postopek odobritve.
The above transitional provision would be to the advantage of all the parties concerned, including the authorities responsible for the authorisation procedure.
Priloga, točka 7 a (novo) za točko 'Brez nasičenih maščob'
Annex, point 7 a (new) after point 'Saturated Fat-Free'
ČISTI OGLJIKOVI HIDRATI
NET CARBOHYDRATES