natgillin/translations-raw huggingface dataset:
Znanstveni podatki in druge informacije, ki jih vsebuje dokumentacija vlagatelja, zahtevana v skladu s členom 10 in zaščitena po členu 19, se v sedmih letih od datuma dovoljenja ne smejo uporabiti v prid drugega vlagatelja, razen, če se je drugi vlagatelj dogovoril s prvim vlagateljem, da se lahko takšni podatki in informacije uporabijo.
Scientific data and other information in the application dossier required under Article 10 which is protected under Article 19, may not be used for the benefit of another applicant for a period of 7 years from the date of authorisation, unless the second applicant has agreed with the first that such data and information may be used.
Člen 19c Spoštovanje pridobljenih pravic
Article 19c Respect of acquired rights
Oddaja vloge, priznanje sprejema ali odobritev dovoljenja za podatke ne posega v nobeno pravico do intelektualne lastnine, ki jo lahko ima vlagatelj do podatkov ali do katerih koli znanstvenih podatkov ali informacij iz dokumentacije vlagatelja.
The submission of an application, the acknowledgement of receipt or the granting of an authorisation for a claim are made without prejudice to any intellectual property rights that the applicant may have on that claim or on any scientific data or information included in the application dossier.
Zgoraj omenjene pravice se obravnavajo v skladu z zakonodajo Skupnosti ali kakršno koli določbo nacionalne zakonodaje, ki ni v nasprotju z zakonodajo Skupnosti.
The abovementioned rights will be considered in accordance with Community law or with any provision of any national law that is not in contradiction with Community law.
Predlog spremembe 55
Amendment 55
Kjer se sklicuje na ta člen, velja postopek, določen v odstavkih 2, 3 in 4.
Where reference is made to this Article, the procedure laid down in paragraphs 2, 3 and 4 shall apply.
Predlog spremembe 56
Amendment 56
Člen 21, odstavek 3
Article 21, paragraph 3
Komisija se posvetuje s Stalnim odborom za prehranjevalno verigo in zdravje živali, ustanovljenim s členom 58(1) Uredbe (ES) št. 178/2002 (v nadaljnjem besedilu „Odbor“) , če meni, da bi bil tak posvet koristen, ali če tako zahteva država članica, ter predloži mnenje o predvidenih ukrepih.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002 (hereinafter referred to as the "Committee") if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Komisija se posvetuje s Stalnim odborom za prehranjevalno verigo in zdravje živali, ustanovljenim s členom 58(1) Uredbe (ES) št. 178/2002, če meni, da bi bil tak posvet koristen, ali če tako zahteva država članica, ter predloži mnenje o predvidenih ukrepih.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002 if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Opredelitev je nepotrebna in neuporabna.
Definition not required, not useful.
Predlog spremembe 57
Amendment 57
Če ima država članica resne pomisleke, da se zahteva ne ujema s to uredbo ali da je znanstvena utemeljitev iz člena 7 pomanjkljiva, lahko ta država članica 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.
V skladu s postopkom iz člena 23(2) se sprejme odločba, kjer je primerno, po pridobitvi mnenja upravnega organa.
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 ta postopek na lastno pobudo.
The Commission may initiate this procedure on its own initiative.
Predlog dovoljuje posameznim državam članicam, da določijo možne dolgotrajne postopke za odobritev podatkov, in jim daje možnost začasnega preklica uporabe podatkov.
The proposal allows individual Member States to set potentially lengthy procedures for approval of claims and grants them the possibility to temporarily suspend the use of claims.
To se zdi nesorazmerno s cilji uredbe ter lahko znatno poveča stroške za podjetja in ovira čezmejno dobavo blaga.
This appears to be disproportionate to the aims of the regulation and could massively increase costs to business whilst discouraging the cross-border provision of goods.
Predlog spremembe 58
Amendment 58
Člen 23, odstavek 1
Article 23, paragraph 1
Komisiji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali, ustanovljen s členom 58(1) Uredbe (ES) št. 178/2002, v nadaljnjem besedilu „Odbor“.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002, hereafter referred to as the "Committee".
Komisiji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali, ustanovljen s členom 58(1) Uredbe (ES) št. 178/2002.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002.
Predlog spremembe 59
Amendment 59
Člen 23, odstavek 2, pododstavek 2
Article 23, paragraph 2, subparagraph 2
Obdobje, določeno v členu 5(6) Sklepa 1999/468/ES, je tri mesece.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.
Obdobje, določeno v členu 5(6) Sklepa 1999/468/ES, ni daljše od dveh mesecev.
The period laid down in Article 5(6) of Decision 1999/468/EC shall not exceed two months.
Da se skrajšajo dolgotrajni postopki, se časovno obdobje omeji na 2 meseca.
In order to reduce lengthy procedures, the time period shall be limited to 2 months.
Ta predlog spremembe bi kazal tudi slednje in duh člena 5(6) Sklepa 1999/468/ES, ki ne navaja, da obdobje traja „tri mesece“, kot je sedaj navedeno v predlagani uredbi, vendar predvideva, da mora biti ustrezno obdobje „določeno v vsakem temeljnem aktu“ in „ne sme v nobenem primeru presegati treh mesecev od datuma sklicevanja na Svet“.
This amendment would also reflect the letter and the spirit of Art. 5(6) of Decision 1999/468/EC which does not state that the period “shall be three months” as currently phrased in the proposed Regulation but provides that relevant period should be "laid down in each basic instrument" and "in no case exceed three months from the date of referral to the Council".
Komisija do ... najpozneje [zadnjega dne petega meseca po datumu sprejema + šest let ] Evropskemu parlamentu in Svetu predloži poročilo o izvajanju te direktive, še zlasti o razvoju trga živil, za katere se naredijo prehranske navedbe ali zdravstven trditve, vključno s predlogom sprememb, če je to potrebno.
By … at the latest [last day of the fifth month following date of adoption + 6 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market of foods in respect of which nutrition or health claims are made, together with a proposal for amendments if necessary.
Komisija do ... najpozneje [zadnjega dne petega meseca po datumu sprejema + tri leta ] Evropskemu parlamentu in Svetu predloži poročilo o izvajanju te direktive, zlasti o razvoju trga živil, za katere se naredijo prehranske navedbe ali zdravstven trditve ter o katerih koli težavah, s katerimi so se srečali pri izvajanju člena 1(2a), vključno s predlogom sprememb, če je to potrebno.
By … at the latest [last day of the fifth month following date of adoption + 3 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market of foods in respect of which nutrition or health claims are made and on any difficulties encountered in the application of the Article 1(4a) , together with a proposal for amendments if necessary.
Zdravstvene trditve, ki so različne od tistih iz člena 12(1), namenjene za živila, kategorije živil ali sestavine živil, se lahko še naprej uporabljajo v času, ko začne ta uredba veljati, 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 used for foods, categories of foods or food constituents, in compliance with provisions already in force at the time when this Regulation enters into force may continue to be made, provided that an application is made pursuant to Article 14 within twelve months of the entry into force of this Regulation, until six months after a final decision is taken pursuant to Article 16.
V primeru takšnih zahtevkov časovni roki iz členov 15(1), 15(2) in 16(1) ne veljajo.
In the case of such applications, the time limits provided for in Articles 15(1)and (2) and 16(1) shall not apply.
Bistveno je, da se predvidi prehodno obdobje, ki omogoča, da obstoječi, znanstveno utemeljeni, pravno zavezujoči podatki ostanejo v uporabi, dokler so ustrezno vključeni v skladu s predlagano uredbo.
It is essential to provide for a transition period that allows existing, science-based, legally made claims to remain in use until they are appropriately brought under the proposed regulation.
Člen 25 b (novo)
Article 25 b (new)
Zahteve za živila z visoko energijsko porabo, ki so bila uporabljena v skladu z nacionalnimi določili pred začetkom veljavnosti te uredbe, se lahko še naprej vlagajo do sprejetja direktive Komisije o živilih, namenjenih osebam z visoko energijsko porabo, zlasti športnikom, na podlagi Direktive 89/398/EGS z dne 3. maja 1989 o približevanju zakonodaje držav članic o živilih za posebne prehranske namene¹.
Claims on food for intense muscular effort which have been used in compliance with national provisions before the entry into force of this Regulation, may continue to be made until the adoption of the Commission Directive on foods intended to meet the expenditure of intense muscular effort, especially for sports people, based on Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses¹.
¹ UL L 186, 30.6.1989, str.
¹ UL L 186, 30.6.1989, p.
Evropska Komisija se zdaj ukvarja z direktivo Komisije o živilih z visoko energijsko porabo, v skladu z okvirno direktivo o živilih za posebne prehranske namene (Direktiva 89/398).
The European 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).
Prihodnja direktiva bo pojasnila potrebe po zahtevah v športni prehrani.
This upcoming Directive will clarify the requirements for claims in sports foods.
Zahteve za proizvode, ki jih uporabljajo športniki, so posebne in zato posebna direktiva omogoča določitev ustreznih meril za te zahteve.
These claims are very specific to products used by athletes and therefore the specific Directive enables the appropriate claims criteria to be defined.
Zato 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.
Uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Živila, dana na trg ali označena pred tem datumom, ki niso v skladu s to uredbo, se smejo 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, ki so dana na trg ali označena pred datumom veljavnosti te uredbe in niso v skladu s to uredbo, se smejo tržiti do [zadnjega dne enajstega meseca po vlogi ] ali do poteka roka uporabe – upošteva se daljše obdobje.
Foods placed on the market or labelled prior to the date of application of this Regulation and which do not comply with this Regulation may be marketed until [last day of the eleventh month following its application] or the end of their shelf life, which ever is longer.
Zdravstvene trditve iz člena 12(1) se lahko navajajo od datuma začetka veljavnosti te uredbe, določenega v členu 26, do sprejetja seznama iz člena 12(2), za katere so odgovorni nosilci dejavnosti pod pogojem, da so v skladu s to uredbo in obstoječimi nacionalnimi določili, ki veljajo zanje, in brez poseganja v sprejetje prehodnih ukrepov iz člena 25 a.
Health claims as referred to in Article 12(1) may be made from the date of entry into force of this Regulation specified in Article 26 until the adoption of the list referred to in Article 12(2), 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 transition measures as referred to in Article 22.
Predlog spremembe 64
Amendment 64
Priloga, pred naslovom „Nizka energijska vrednost“ (novo)
Annex, before Low energy (new)
Brez poseganja v prehranske navedbe, navedene v Prilogi, se dovolijo navedbe dejstev, ki se jih da podkrepiti in ki so v skladu s splošnimi načeli, določenimi v členu 3, kot npr. kaloričnost ali druge hranilne vrednosti.
Without prejudice to nutrition claims listed in the Annex, statements of facts capable of substantiation and which comply with the general principles laid down in Article 3, such as calorific content or other nutritional characteristics, shall be permitted.
Predlog bi sedaj prepovedal navedbe dejstev, kot so „vsebuje manj kot 300 kalorij“ ali vsebuje „dva grama soli“.
The proposal would currently prohibit statements of fact, such as “contains less than 300 calories” or contains “two grams of salt”.
Takšni opisi bi morali biti dovoljeni, ker so bistveni znanstveno utemeljeni podatki in niso v nasprotju s splošnimi načeli iz člena 3 predloga.
Such descriptions should be allowed since they are essentially statements of scientific fact and are not contravening the general principles provided in Art. 3 of the proposal.
Zato je treba za ta namen v začetek Priloge vključiti splošno klavzulo.
For this reason, a general clause to this effect should be included in the beginning of the Annex.
Priloga Prehranske navedbe in pogoji, ki veljajo zanje (Dodatna navedba za oddelkom „NIZKA ENERGIJSKA VREDNOST“)
Annex Nutrition claims and conditions applying to them (Additional claim - to be placed after "LOW ENERGY")
VISOKA ENERGIJSKA VREDNOST
HIGH ENERGY
Navedba, da ima živilo visoko energijsko vrednost, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode z vsebnostjo več kot 60 kcal/100 ml ali 250 kcal/100 g.
A claim that a food is high in energy, and any claim likely to have the same meaning for the consumer, may only be made where the product contains more than 60 kcal/100ml or 250 kcal/100g.
Člen 2.4 zagotavlja opredelitev „prehranskih navedb“ in v točki (a) velja za energijo (kalorična vrednost), ki jo živilo „zagotovi pri znižani ali povečani stopnji“.
Article 2.4 provides a definition for "nutrient claim", and refers in point (a) to the energy (calorific value)a food "provides at a reduced or increased rate".
Predlog spremembe 66
Amendment 66
Priloga, „Nizka vsebnost maščob“
Annex, Low fat
Navedba, da je živilo z nizko vsebnostjo maščob, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode z vsebnostjo ne več kot 3 g maščobe na 100 g ali 1,5 g maščobe na 100 ml (1,8 g maščobe na 100 ml za polposneto mleko).
A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 3g of fat per 100g or 1.5g of fat per 100ml (1.8g of fat per 100 ml for semi-skimmed milk).
Ta navedba se uporablja brez poseganja v izraz „nizka vsebnost maščob“, kakor je predviden v členu 5 Uredbe (ES) št. 2991/94.
This claim shall apply without prejudice to the term “low fat” as provided for in Article 5 of Regulation (EC) No 2991/94.
Navedba „nizka vsebnost maščob“ se lahko uporablja tudi za sir, če je vsebnost maščobe vsaj 10 %, vendar manj kot 25 % suhe snovi sira.
A "low fat" claim may also be applied to cheese if the fat content is more than 10% but less than 25% of the dry matter of cheese.
Pri proizvodih, ki imajo nizko vsebnost maščob, lahko navedba o tem nosi predpono „naravno“.
In the case of foods naturally low in fat, the term "naturally" may be used as a prefix to this claim.
Navedbe ne bi smele veljati za mazave maščobe, za katere Uredba (ES) 2991/94 določa ločena pravila.
Claims should not apply to spreadable fats, for which Regulation (EC) 2991/94 provides separate rules.
V skladu z Uredbo (ES) 2991/94 se lahko sklicevanje na „lažji“ navezuje na proizvod, če je njegova vsebnost maščobe 41-62 %, in sklicevanje na „nizka vsebnost maščob“, „lahko“, če vsebnost maščobe proizvoda ni višja od 41 %.
According to Regulation (EC) 2991/94, a reference to "lighter" can be attached to a product if its fat content is 41-62 % and a reference to "low fat", "light" if the fat content of the product is not more than 41 %.
V skladu s točko 23 obrazložitvenega memoranduma Komisije se Uredba (ES) 2991/94 prilagodi tej uredbi.
According to point 23 of the Commission's explanatory memorandum, Regulation (EC) 2991/94 is meant to be adjusted.
Uredba (ES) 2991/94 zadeva le mazave maščobe.
It concerns only spreadable fats.
Le s težavo se da prilagoditi splošni uredbi, ki zadeva vse živilske proizvode.
It can hardly be fully adjusted to a general regulation that concerns all food products.
Treba je jasno navesti, da se navedbe o količini maščobe ne bodo uporabljali za hranilnost namazov brez poseganja v uredbo.
It should be clearly stated that claims on the quantity of fat will not be applied to the spreadable nutritional fats without prejudice to it.
Predlog spremembe 67
Amendment 67
Navedba, da je živilo brez maščob, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode z vsebnostjo ne več kot 0,5 g maščobe na 100 g ali 100 ml.
A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.5g of fat per 100g or 100ml.
Vendar pa se navedbe, izražene v „X % brez maščob“, prepovejo.
However, claims expressed as "X% fat-free" shall be prohibited.
Navedba „brez maščob“ se lahko uporablja tudi za sir, če je vsebnost maščobe manjša od 10 % suhe snovi sira.
A "fat-free" claim may also be applied to cheese if the fat content is less than 10% of the dry matter of cheese.
Pri proizvodih, ki so brez maščob, lahko navedba o tem nosi predpono „naravno“.
In the case of foods naturally fat-free, the term "naturally" may be used as a prefix to this claim.
Navedba mora veljati za sire z določeno vsebnostjo maščob.
The claim should apply to cheeses with particular fat content.
V skladu s standardi IDF in Codexa za sir ter, na primer, v skladu z ustrezno finsko zakonodajo, se lahko sir obravnava kot brez maščob, če je vsebnost maščob suhe snovi manj kot 10 %.
According to standards of the IDF and Codex applicable to cheeses and, for instance, the relevant Finnish legislation, cheese can be regarded as fat free, if the fat content of the dry matter is less than 10 %.
Predlog spremembe 68
Amendment 68
Priloga, po naslovu Brez nasičenih maščob (novo)
Annex, after Saturated fat-free (new)
VISOKA VSEBNOST NENASIČENIH MAŠČOB in/ali VISOKA VSEBNOST TEKOČIH MAŠČOB
HIGH UNSATURATED FAT and/or HIGH SOFT FAT
Navedba, da ima živilo visoko vsebnost nenasičenih maščob/tekočih maščob, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode, v katerih so nenasičene maščobe najmanj 70 % vseh maščob.
A claim that a food is high in unsaturated fat/soft fat, and any claim likely to have the same meaning for the consumer, may only be made where the amount of unsaturated fat is at least 70% of the total fat content in the product.
Pri živilih, ki imajo naravno visoko vsebnost nenasičenih maščob in/ali tekočih maščob, lahko navedba o tem nosi predpono „naravno“.
In the case of foods naturally high in unsaturated fat and/or soft fat, the term "naturally" may be used as a prefix to this claim.
Morale bi biti omogočene tudi navedbe o kakovosti maščob in ne le o vsebnosti nasičenih maščob.
It should be possible to make claims also on the quality of fat and not only on the content of saturated fat.
Na primer, morale bi biti omogočene navedbe, da ima proizvod „visoko vsebnost polinenasičenih maščob“, „visoko vsebnost mononenasičenih maščob“ in „visoko vsebnost omega-3 maščob“.
For example, it should be possible to claim that the product is ”high in polyunsaturated fat”, “high in monounsaturated fat” and “high in omega-3-fat”.
Zato je treba določiti nekatere pogoje za uporabo navedb „visoka vsebnost nenasičenih maščob in/ali visoka vsebnost tekočih maščob“.
Therefore, certain conditions should be established for the use of a claim "high unsaturated fat and/or high soft fat".
Med kakovostjo in hranilno vrednostjo različnih maščob so velike razlike.
There are concrete differences in the quality and nutritional value of different fats.
Priznano je, da imajo maščobe z visoko vsebnostjo nenasičenih maščobnih kislin blagodejne učinke na človeško prehrano, posebno ko v prehrani nadomestijo nasičene ali trde maščobe.
Fats containing high amounts of unsaturated fatty acids are recognised to have a beneficial impact on human nutrition especially when replacing saturated or hard fats in the diet. .
Predlog spremembe 69
Amendment 69
Priloga, po novem naslovu Visoka vsebnost nenasičenih maščob in/ali visoka vsebnost tekočih maščob (novo)
Annex, after new High unsaturated fat and/or High soft fat (new)
VISOKA VSEBNOST POLINENASIČENIH MAŠČOB
HIGH POLY UNSATURATED FAT
Navedba, da ima živilo visoko vsebnost polinenasičenih maščob, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode, v katerih najmanj 45 % maščobnih kislin izhaja iz polinenasičenih maščob (PUFA).
A claim that a food is high in poly unsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids in the product is derived from polyunsaturated fat (PUFA).
Pri živilih, ki imajo naravno visoko vsebnost polinenasičenih maščob, lahko navedba o tem nosi predpono „naravno“.
In the case of foods naturally high in poly unsaturated fat, the term "naturally" may be used as a prefix to this claim.
Predlagana raven (vsaj 45 %) je v številnih državah že dolga leta uspešno vključena v zakonodajo ali kodekse ravnanja in je namenjena povečanju zaužite količine polinenasičenih maščob (PUFA) med prebivalstvom.
The proposed level (at least 45 %) has been successfully incorporated into legislation or Codes of Practice for many years in a number of countries to improve the PUFA intake by the population.
Predlog spremembe 70
Amendment 70
Priloga, po novem naslovu Visoka vsebnost polinenasičenih maščob (novo)
Annex, after new High poly unsaturated fat (new)
Navedba, da ima živilo visoko vsebnost mononenasičenih maščob, in katera koli navedba s podobnim pomenom za potrošnika lahko velja le za proizvode, v katerih najmanj 45 % maščobnih kislin izhaja iz mononenasičenih maščob (MUFA).
A claim that a food is high in monounsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids in the product is derived from monounsaturated fat (MUFA).
Pri živilih, ki imajo naravno visoko vsebnost mononenasičenih maščob, lahko navedba o tem nosi predpono „naravno“.
In the case of foods naturally high in mono unsaturated fat, the term "naturally" may be used as a prefix to this claim.