natgillin/translations-raw huggingface dataset:
Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched.
Ker se podatki lahko vnašajo v vseh uradnih jezikih Skupnosti, je treba uporabljati numerično oznako, ki omogoča enostavno iskanje pripomočkov.
The Global Medical Device Nomenclature that has been developed based on EN ISO 15225:2000 Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange is such an internationally recognised nomenclature.
Globalna nomenklatura o medicinskih pripomočkih, ki je bila vzpostavljena na podlagi EN ISO 15225: 2000 Nomenklatura – Specifikacija za sistem nomenklature o medicinskih pripomočkih za namen izmenjave regulatornih podatkov, je takšna mednarodno priznana nomenklatura.
The need to establish and maintain Eudamed and to start implementing the Global Medical Device Nomenclature as a basis for that databank was recalled in the Council Conclusions of 2 December 2003 on Medical Devices [4].
Svet je v svojih sklepih z dne 2. decembra 2003 o medicinskih pripomočkih [4] ugotovil, da je treba vzpostaviti in vzdrževati Eudamed ter začeti uporabljati Globalno nomenklaturo o medicinskih pripomočkih kot podlago za navedeno banko podatkov.
An appropriate transitional period is necessary to allow Member States to prepare for the mandatory use of Eudamed and to take account of the changes introduced by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market [5].
Zagotoviti je treba ustrezno prehodno obdobje, da se lahko države članice pripravijo na obvezno uporabo Eudameda in da upoštevajo spremembe, uvedene z Direktivo 2007/47/ES Evropskega parlamenta in Sveta z dne 5. septembra 2007 o spremembah Direktive Sveta 90/385/EGS o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev, Direktive Sveta 93/42/EGS o medicinskih pripomočkih in Direktive 98/8/ES o dajanju biocidnih pripravkov v promet [5].
Member States should only be required to enter data existing before 1 May 2011 to the extent required for the future functioning of Eudamed.
Države članice morajo biti obvezane le za vnašanje podatkov, ki obstajajo do 1. maja 2011, v obsegu, ki je potreben za prihodnje delovanje Eudameda.
It is necessary for the completeness of Eudamed to enter data existing before 1 May 2011 on the manufacturer, the authorised representative and on device registration, which are required by Directives 93/42/EEC and 98/79/EC, in the form in which such data are available at national level.
Za popolno delovanje Eudameda je treba v skladu z zahtevami iz direktiv 93/42/EGS in 98/79/ES vnesti podatke o registraciji proizvajalcev, pooblaščenih zastopnikov in pripomočkov, ki obstajajo do 1. maja 2011, v obliki, v kateri so na voljo na nacionalni ravni.
The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices,
Ukrepi, predvideni s tem sklepom, so v skladu z mnenjem Odbora za medicinske pripomočke –
This Decision establishes the European Databank on Medical Devices (Eudamed) as databank for the purposes of Article 10b(3) of Directive 90/385/EEC, Article 14a(3) of Directive 93/42/EEC and Article 12(3) of Directive 98/79/EC.
Ta sklep vzpostavlja evropsko banko podatkov za medicinske pripomočke (Eudamed) kot banko podatkov za namene člena 10b(3) Direktive 90/385/EGS, člena 14a(3) Direktive 93/42/EGS in člena 12(3) Direktive 98/79/ES.
Member States shall ensure that the data referred to in points (a) and (b) of Article 10b(1) of Directive 90/385/EEC, points (a), (b) and (c) of Article 14a(1) of Directive 93/42/EEC and points (a), (b) and (c) of Article 12(1) of Directive 98/79/EC, are entered into Eudamed in accordance with the Annex to this Decision.
Države članice zagotovijo, da se podatki iz točk (a) in (c) člena 10b(1) Direktive 90/385/EGS, točk (a), (b) in (c) člena 14a(1) Direktive 93/42/EGS in točk (a), (b) in (c) člena 12(1) Direktive 98/79/ES vnašajo v Eudamed v skladu s Prilogo k temu sklepu.
For clinical investigations Member States shall ensure that an extract of the notifications referred to in Article 10(1) of Directive 90/385/EEC and in Article 15(1) of Directive 93/42/EEC, as well as the information referred to in Article 10(3) and (4) of Directive 90/385/EEC and in Article 15(6) and (7) of Directive 93/42/EEC are entered into Eudamed in accordance with the Annex to this Decision.
V zvezi s kliničnimi preiskavami države članice zagotovijo, da se izvleček obvestil iz člena 10(1) Direktive 90/385/EGS in člena 15(1) Direktive 93/42/EGS ter informacije iz člena 10(3) in (4) Direktive 90/385/EGS in člena 15(6) in (7) Direktive 93/42/EGS vnašajo v Eudamed v skladu s Prilogo k temu sklepu.
Eudamed shall use the Hypertext Transfer Protocol Secure (HTTPS) and the Extensible Mark-up Language (XML).
Eudamed uporablja zaščiten Hypertext Transfer Protocol (HTTPS) in Extensible Mark-up Language (XML).
When entering data in Eudamed, Member States may choose between on-line data entry and up-loading of XML files.
Pri vnašanju podatkov v Eudamed lahko države članice izbirajo med spletnim vnašanjem podatkov in naložitvijo XML datotek.
Member States shall ensure that when entering data into Eudamed medical devices are described using a code from an internationally recognised nomenclature for medical devices.
Države članice zagotovijo, da se pri vnašanju podatkov v Eudamed za medicinske pripomočke uporabljajo oznake iz mednarodno priznane nomenklature o medicinskih pripomočkih.
As concerns data existing before the date referred to in Article 6, Member States shall ensure that the data on registration of manufacturers, authorised representatives and devices are entered into Eudamed in accordance with Article 14a(1)(a) of Directive 93/42/EEC and Article 12(1)(a) of Directive 98/79/EC.
V zvezi s podatki, ki obstajajo pred datumom iz člena 6, države članice zagotovijo, da se v Eudamed vnašajo podatki o registraciji proizvajalcev, pooblaščenih zastopnikov in pripomočkov v skladu s členom 14a(1)(a) Direktive 93/42/EGS in členom 12(1)(a) Direktive 98/79/ES.
That data shall be entered by 30 April 2012 at the latest.
Navedeni podatki se vnesejo najpozneje do 30. aprila 2012.
Member States shall apply this Decision from 1 May 2011.
Države članice uporabljajo ta sklep od 1. maja 2011.
Table detailing the mandatory data fields in the respective module in the Eudamed databank according to the obligations arising from Directives 93/42/EEC, 90/385/EEC and 98/79/EC
Preglednica obveznih podatkov v ustreznih modulih v banki podatkov Eudamed v skladu z obveznostmi iz direktiv 93/42/EGS, 90/385/EGS in 98/79/ES
Directive 93/42/EEC
Direktiva 93/42/EGS
Minimum data required for Eudamed data entry
Najmanjši obseg podatkov, ki se zahteva za vnos v Eudamed
Article 14a(1)(a) and Article 14(1) and (2)
člen 14a(1)(a) in člen 14(1) in (2)
Actor (manufacturer/authorised representative):
Subjekt (proizvajalec/pooblaščeni zastopnik):
Name;
ime;
Locality;
kraj;
Postcode;
poštna številka;
Country;
država;
Phone or E-mail;
telefonska številka ali e-naslov;
Role.
vloga.
Device:
Pripomoček:
Internationally recognised nomenclature code (for data generated after 1 May 2011);
oznaka mednarodno priznane nomenklature (za podatke po 1. maju 2011);
Device Name/Make or, where not available, generic name.
ime/znamka pripomočka ali, kadar ni na voljo, generično ime.
Article 14a(1)(b)
člen 14a(1)(b)
Certificate:
Potrdilo:
Certificate number;
številka potrdila;
Certificate type;
vrsta potrdila;
Date of Issue;
datum izdaje;
Expiration Date;
datum prenehanja veljavnosti;
Manufacturer and, if applicable, authorised representative (see fields under 1.
proizvajalec in, kadar je ustrezno, pooblaščeni zastopnik (glej rubrike pod 1.
Notified Body (selected from system);
priglašeni organ (izbran iz sistema);
General Scope description and, where applicable, details on device (see fields under 2.
splošen opis in, kadar je ustrezno, podroben opis pripomočka (glej rubrike pod 2.
Device);
Pripomoček):
Status and, where applicable, reasons for decision of Notified Body.
status in, kadar je ustrezno, razlogi za odločitev priglašenega organa.
Article 14a(1)(c) and Article 10(3)
člen 14a(1)(c) in člen 10(3)
Incident (National Competent Authority Report):
Zaplet (poročilo nacionalnega pristojnega organa):
Competent Authority reference;
referenca pristojnega organa;
Manufacturer, where applicable authorised representative (see fields under 1.
proizvajalec oz. pooblaščeni zastopnik (glej rubrike pod 1.
Manufacturer contact;
kontaktni podatki proizvajalca;
Manufacturer reference/Field Safety Corrective Action (FSCA) nr.;
referenca proizvajalca/št. popravljalnega ukrepa za varnost na področju (FSCA);
Device (see fields under 2.
pripomoček (glej rubrike pod 2.
Device), plus where applicable lot number, serial number, software version;
Pripomoček) in, kadar je ustrezno, številka pošiljke, serijska številka, različica programske opreme;
Device known to be in the market in;
pripomoček, za katerega je znano, da je na trgu;
Confidential;
zaupno;
Complete investigation;
popolna preiskava;
Background Information (Description);
ozadje (opis);
Conclusion;
sklep;
Recommendation;
priporočilo;
Action and action description.
ukrep in opis ukrepa.
Article 14a(1)(d) and Article 15(1), (6) and (7)
člen 14a(1)(d) in člen 15(1), (6) in (7)
Clinical Investigation:
Klinična preiskava:
Title of investigation;
naslov preiskave;
Protocol number;
številka protokola;
Primary objective;
osnovni cilj;
Competent Authority Contact for this Clinical Investigation;
kontaktni podatki organa, pristojnega za to klinično preiskavo;
Decisions taken by Competent Authority pursuant to Article 15(6), date of decision and grounds;
odločitve pristojnega organa v skladu s členom 15(6), datum odločitve in utemeljitev;
Early termination on safety grounds pursuant to Article 15(7), date of decision and grounds.
predčasna prekinitev zaradi varnostnih razlogov v skladu s členom 15(7), datum odločitve in utemeljitev.
Directive 90/385/EEC
Direktiva 90/385/EGS
Article 10b(1)(a)
člen 10b(1)(a)
Certificate (see fields under 3.
Potrdilo (glej rubrike pod 3.
Certificate)
Potrdilo)
Article 10b(1)(b) and Article 8(3)
člen 10b(1)(b) in člen 8(3)
Incident (see fields under 4.
Zaplet (glej rubrike pod 4.
Incident)
Zaplet)
Article 10b(1)(c) and Article 10(1), (3) and (4)
člen 10b(1)(c) in člen 10(1), (3) in (4)
Clinical Investigation (see fields under 5.
Klinična preiskava (glej rubrike pod 5.
Clinical Investigation, (a) to (f)):
Klinična preiskava, (a) do (f))
Decisions taken by Competent Authority pursuant to Article 10(3), date of decision and grounds;
odločitve pristojnega organa v skladu s členom 10(3), datum odločitve in utemeljitev;
Early termination on safety grounds pursuant to Article 10(4), date of decision and grounds.
predčasna prekinitev zaradi varnostnih razlogov v skladu s členom 10(4), datum odločitve in utemeljitev.
Directive 98/79/EC
Direktiva 98/79/ES
Article 12(1)(a) and Article 10(1), (3) and (4) and Annex VIII (4)
člen 12(1)(a), člen 10(1), (3) in (4) ter Priloga VIII (4)
Actor (for all in vitro diagnostic medical devices (IVD’s):
Subjekt (za vse in vitro diagnostične medicinske pripomočke (IVD)
Address of manufacturer, respectively authorised representative (see fields under 1.
Naslov proizvajalca oz. pooblaščenega zastopnika (glej rubrike pod 1.
Actor).
Subjekt);
For all IVD’s
za vse IVD:
Device (see fields under Device 2.);
pripomoček (glej rubrike pod 2. Pripomoček);
Information on whether device is ‘new’;
informacije, ali je pripomoček „nov“;
Discontinuation of placing on the market.
prekinitev dajanja na trg.
In addition for Annex II and self-testing
Dodatno za Prilogo II in samotestiranje
Outcome of performance evaluation, where applicable;
rezultat ovrednotenja delovanja, kadar je ustrezno;
Certificates (see fields under 3.
potrdila (glej rubrike pod 3.
Certificate);
Potrdilo);
Conformity with Common Technical Specifications, where applicable;
skladnost s skupnimi tehničnimi specifikacijami, kadar je ustrezno;
Identification of device.
identifikacija pripomočka.
Article 12(1)(c) and Article 11(3)
člen 12(1)(c) in člen 11(3)
of 21 April 2010
z dne 21. aprila 2010
authorising the placing on the market of puree and concentrate of the fruits of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi dajanja na trg pireja in koncentrata sadežev Morinda citrifolia kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document C(2010) 2397)
(notificirano pod dokumentarno številko C(2010) 2397)
On 20 April 2006 Tahitian Noni International Inc. made a request to the competent authorities of Belgium to place puree and concentrate of the fruits of Morinda citrifolia on the market as a novel food ingredient.
Družba Tahitian Noni International Inc. je 20. aprila 2006 pri pristojnih organih Belgije vložila zahtevek za dajanje na trg pireja in koncentrata sadežev Morinda citrifolia kot nove živilske sestavine.
On 28 February 2007 the competent food assessment body of Belgium issued its initial assessment report.
Pristojni organ Belgije za ocenjevanje živil je 28. februarja 2007 izdal začetno poročilo o oceni.
In that report it came to the conclusion that the use of the puree and concentrate of the fruits of Morinda citrifolia as a food ingredient was acceptable.
V navedenem poročilu je ugotovil, da je uporaba pireja in koncentrata sadežev Morinda citrifolia kot živilske sestavine sprejemljiva.
The Commission forwarded the initial assessment report to all Member States on 28 March 2007.
Komisija je 28. marca 2007 vsem državam članicam poslala začetno poročilo o oceni.
Therefore the European Food Safety Authority (EFSA) was consulted on 7 November 2007.
Zato je bil 7. novembra 2007 opravljen posvet z Evropsko agencijo za varnost hrane (EFSA).
On 13 March 2009, EFSA in the ‘Scientific opinion of the Panel on Dietetic Products Nutrition and Allergies’ on a request from the European Commission on the safety of ‘Morinda citrifolia (Noni) fruit puree and concentrate’ as a novel food ingredient came to the conclusion that the Noni fruit puree and concentrate was safe for the general population.
EFSA je 13. marca 2009 v „Znanstvenem mnenju znanstvenega sveta za dietetične izdelke, prehrano in alergije na zahtevo Komisije v zvezi z varnostjo pireja in koncentrata sadežev Morinda citrifolia (Noni)“ kot nove živilske sestavine ugotovila, da sta sadni pire in koncentrat Noni varna za splošno prebivalstvo.
On the basis of the scientific assessment, it is established that the fruit puree and concentrate from Morinda citrifolia (Noni) complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Iz znanstvene ocene izhaja, da sadni pire in koncentrat Morinda citrifolia (Noni) izpolnjujeta merila iz člena 3(1) Uredbe (ES) št. 258/97.
Morinda citrifolia (Noni) fruit puree and concentrate as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses listed in Annex II.
Sadni pire in koncentrat Morinda citrifolia (Noni), kot sta opredeljena v Prilogi I, se lahko dasta na trg v Uniji kot nova živilska sestavina za namen uporabe iz Priloge II.
The designation of the Morinda citrifolia fruit puree authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Morinda citrifolia fruit puree’ or ‘Noni fruit puree’.
Oznaka sadnega pireja Morinda citrifolia, odobrenega s tem sklepom, na embalaži živil, ki ga vsebujejo, je „sadni pire Morinda citrifolia“ ali „sadni pire Noni“.
The designation of the Morinda citrifolia fruit concentrate authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’.
Oznaka sadnega koncentrata Morinda citrifolia, odobrenega s tem sklepom, na embalaži živil, ki ga vsebujejo, je „sadni koncentrat Morinda citrifolia“ ali „sadni koncentrat Noni“.
This Decision is addressed to Tahitian Noni International Inc., 333 West River Park Drive, Provo, Utah 84604, USA
Ta sklep je naslovljen na družbo Tahitian Noni International Inc., 333 West River Park Drive, Provo, Utah 84604, ZDA
Done at Brussels, 21 April 2010.
V Bruslju, 21. aprila 2010
Specifications of Morinda citrifolia fruit puree and concentrate
Specifikacije sadnega pireja in koncentrata Morinda citrifolia
The fruits of Morinda citrifolia are harvested by hand.
Sadeži Morinda citrifolia so ročno obrani.
Seeds and skin are separated mechanically from the pureed fruits.
Pečke in lupina so mehanično ločene od sadežev za pire.
After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.
Po pasterizaciji se pire pakira v aseptičnih posodah in shrani na hladnem.
Morinda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50-60 °C for 1-2 h).
Koncentrat Morinda citrifolia se pripravi iz pireja Morinda citrifolia z obdelavo s pektolitičnimi encimi (50–60 °C za 1–2 uri).
Then the puree is heated to inactivate the pectinases and then immediately cooled.
Pire se nato segreje, da se inaktivirajo pektinaze, zatem pa takoj ohladi.
The juice is separated in a decanter centrifuge.
Sok se loči v dekanter centrifugi.
Afterwards the juice is collected and pasteurised, prior to being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrate.
Nato se sok zbere in pasterizira, še preden se koncentrira v vakuumskem uparjalniku od 6–8 brix do 49–51 brix v končnem koncentratu.
Composition of Morinda citrifolia fruit puree and concentrate
Sestava sadnega pireja in koncentrata Morinda citrifolia
Total carbohydrates
Ogljikovi hidrati
Dietary fibre
Prehranska vlaknina
By an HPLC-UV method developed and validated by the applicant for the analysis of anthraquinones in Morinda citrifolia puree and concentrate.Limits of detection: 2,5 ng/mL (5,15 dimethylmorindol); 50,0 ng/mL (lucidin); 6,3 ng/mL (alizarin) and 62,5 ng/mL (rubiadin).
Z metodo HPLC-UV, ki jo razvije in potrdi prijavitelj za analizo antrakinonov v pireju in koncentratu Morinda citrifolia.Meje zaznavnosti: 2,5 ng/mL (5,15-dimetilmorindol); 50,0 ng/mL (lucidin); 6,3 ng/mL (alizarin) in 62,5 ng/mL (rubiadin).
Uses of Morinda citrifolia fruit puree and concentrate
Uporaba sadnega pireja in koncentrata Morinda citrifolia
Maximum use level of Morinda citrifolia fruit
Največja raven uporabe sadeža Morinda citrifolia
puree
Pire
concentrate
Koncentrat
Candy/Confectionery
Bonboni/slaščice
Powdered nutritional drink mixes (dry weight)
Mešanice hranilnih pijač v prahu (suha masa)
Carbonated beverages
Gazirane pijače
Ice cream & sorbet
Sladoled in sorbet
Buns, cakes & pastries
Štručke, torte in peciva
Breakfast cereal (whole grain)
Žitni kosmiči (polnozrnati)
Jams and jellies (fruit preserves)
Džemi in želeji (vkuhano sadje)
Sweet spreads, fillings and icings
Sladki namazi, nadevi in prelivi
Savoury sauces, pickles, gravies, and condiments
Začinjene omake, vložena zelenjava, omake iz mesnega soka in začimbe
Food supplements (in accordance with Directive 2002/46/EC of the European Parliament and of the Council [2])
Prehranska dopolnila (v skladu z Direktivo 2002/46/ES Evropskega parlamenta in Sveta [2])
26 g per daily dose as recommended by the manufacturer
26 g na dnevni odmerek, kot ga priporoča proizvajalec
6 g per daily dose as recommended by the manufacturer
6 g na dnevni odmerek, kot ga priporoča proizvajalec
Based on pre-processing quantity to produce final 100 g product.
Na podlagi količin predhodne obdelave, iz katere nastane 100 g proizvoda.
of 22 April 2010
z dne 22. aprila 2010
concerning the draft Decree from Italy setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products
o osnutku odloka Italije o določanju standardov, ki urejajo označevanje mleka z dolgim rokom trajanja, steriliziranega mleka, mikrofiltriranega pasteriziranega mleka, pasteriziranega mleka pri visoki temperaturi in mlečnih izdelkov
(notified under document C(2010) 2436)
(notificirano pod dokumentarno številko C(2010) 2436)
In accordance with the procedure provided for in the second paragraph of Article 19 of Directive 2000/13/EC, the Italian authorities notified the Commission on 25 August 2009 of the draft Decree setting out standards governing the labelling of shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk, as well as milk products.
Italijanski organi so 25. avgusta 2009 v skladu s postopkom iz drugega odstavka člena 19 Direktive 2000/13/ES obvestili Komisijo o osnutku odloka o določanju standardov, ki urejajo označevanje mleka z dolgim rokom trajanja, steriliziranega mleka, mikrofiltriranega pasteriziranega mleka, pasteriziranega mleka pri visoki temperaturi in mlečnih izdelkov.
According to Article 1 of the notified Decree, this applies to shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk as well as milk products.
V skladu s členom 1 priglašenega odloka se to uporablja za mleko z dolgim rokom trajanja, sterilizirano mleko, mikrofiltrirano pasterizirano mleko, pasterizirano mleko pri visoki temperaturi in za mlečne izdelke.
Article 2 of the notified Decree requires that the labels of sterilised shelf-stable milk, UHT milk, micro-filtered pasteurised milk and high-temperature pasteurised milk must indicate the place of origin of the milk which has undergone the treatments in question.
Člen 2 priglašenega odloka zahteva, da morajo oznake na steriliziranem mleku z dolgim rokom trajanja, steriliziranem mleku, mikrofiltriranem pasteriziranem mleku in pasteriziranem mleku pri visoki temperaturi vsebovati kraj porekla mleka, ki je bilo obdelano na te načine.
Article 3(1) of the notified Decree provides that the labels of milk products must indicate the place of origin of the milk used in the preparation of such products.
Člen 3(1) priglašenega odloka določa, da morajo oznake mlečnih izdelkov vsebovati kraj porekla mleka, ki je bilo uporabljeno za pripravo teh izdelkov.
Article 3(3) of the notified Decree provides that the labels of cheeses, including cottage cheeses, containing substances obtained from processing milk or milk products must include those substances in the list of ingredients with a reference to the place of origin of the milk used for processing those substances.
Člen 3(3) priglašenega odloka določa, da morajo na oznakah na sirih in skutah, ki vsebujejo snovi, pridobljene pri predelavi mleka ali mlečnih izdelkov, te snovi biti navedene na seznamu sestavin z navedbo kraja porekla mleka, ki je bilo uporabljeno za predelavo teh snovi.
Article 4 of the notified Decree provides that the labels of cheeses obtained from curd must indicate the place of origin of the milk used in the curd.
Člen 4 priglašenega odloka določa, da morajo oznake na sirih, pridobljenih iz sesirjenega mleka, vsebovati kraj porekla mleka, ki je bilo uporabljeno za sesirjenje.
The scope of harmonisation is defined in Article 3(1) of that Directive, which lists all the particulars that are compulsory on the labelling of foodstuffs in accordance with Articles 4 to 17 and subject to the exceptions contained therein.
Obseg usklajevanja je določen v členu 3(1) navedene direktive, ki navaja samo seznam navedb, ki morajo biti obvezno navedene na oznaki živil v skladu s členi 4 do 17 in ob upoštevanju izjem, ki so v njih predvidene.