natgillin/translations-raw huggingface dataset:
In addition, in the process of manufacturing certain goods by-products are obtained which differ markedly in value from the principal products. In some instances these by-products can be used only as animal feed.
Poleg tega nastanejo pri proizvodnji nekaterega blaga stranski proizvodi, katerih vrednost se izrazito razlikuje od vrednosti primarnih proizvodov; v nekaterih primerih se lahko ti stranski proizvodi uporabijo le kot krma za živali.
If the time-limit of three months specified in the third subparagraph is not complied with, the obligation referred to in the first sentence of paragraph 1 cannot be deemed to have been met. The security provided for in Article 43 shall consequently be forfeit in respect of the amount in question.
Če se rok treh mesecev iz tretjega pododstavka prekorači, se šteje, da obveznost iz prvega stavka odstavka 1 ni izpolnjena, zaradi česar se zadrži varščina za zadevni znesek, predvidena v členu 43.
Mannitol
manitol:
Mannitol:
manitol:
The Commission may suspend application of paragraph 2 where the cumulative sum of the amounts of refund certificates which may be issued in accordance with Article 49 of Regulation (EC) No 1291/2000 exceeds EUR 4 million in a budget period. Decisions to suspend shall be published in the Official Journal of the European Union.
Komisija lahko začasno ustavi uporabo odstavka 2, če skupna vsota zneskov potrdil o nadomestilu, ki se lahko izdajo v skladu s členom 49 Uredbe (ES) št. 1291/2000 v proračunskem obdobju presega 4 milijone EUR. Odločitve o začasni ustavitvi uporabe se objavijo v Uradnem listu Evropske Unije.
Commission Regulation (EC) No 1044/2005
Uredba Komisije (ES) št. 1044/2005
amending Regulation (EC) No 2808/98 as regards the operative event for the exchange rate for aid under Regulation (EC) No 1782/2003 and amending Regulation (EC) No 1973/2004
o spremembi Uredbe (ES) št. 2808/98 glede datuma uveljavitve menjalnega tečaja za pomoči, ki izhajajo iz področja uporabe Uredbe (ES) št. 1782/2003, in o spremembi Uredbe (ES) št. 1973/2004
Having regard to Council Regulation (EC) No 2799/98 of 15 December 1998 establishing agrimonetary arrangements for the euro [1], and in particular Article 9 thereof,
ob upoštevanju Uredbe Sveta (ES) št. 2799/98 z dne 15. decembra 1998 o vzpostavitvi kmetijsko-monetarne ureditve za evro [1] in zlasti člena 9 Uredbe,
Having regard to Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers and amending Regulations (EEC) No 2019/93, (EC) No 1452/2001, (EC) No 1453/2001, (EC) No 1454/2001, (EC) No 1868/94, (EC) No 1251/1999, (EC) No 1254/1999, (EC) No 1673/2000, (EEC) No 2358/71 and (EC) No 2529/2001 [2], and in particular Article 145(c) thereof,
ob upoštevanju Uredbe Sveta z dne 29. septembra 2003 o skupnih pravilih za sheme neposrednih podpor v okviru skupne kmetijske politike in o uvedbi nekaterih shem podpor za kmete ter o spremembi uredb (EGS) št. 2019/93, (ES) št. 1452/2001, (ES) št. 1453/2001, (ES) št. 1454/2001, (ES) 1868/94, (ES) št. 1251/1999, (ES) št. 1254/1999, (ES) št. 1673/2000, (EGS) št. 2358/71 in (ES) št. 2529/2001 [2], in zlasti člena 145(c) Uredbe,
Regulation (EC) No 1782/2003 introduces a system of direct aid which is paid out on the basis of a single payment application and is always expressed in euro.
Uredba (ES) št. 1782/2003 je uvedla sistem neposrednih pomoči, katerih izplačevanje temelji na zahtevku za enotno plačilo in katerih vsota je vedno izražena v evrih.
Since no operative events have been laid down for the exchange rate for some of the aid measures provided for in Regulation (EC) No 1782/2003, provision must be made for a uniform operative event directly linked to applications submitted by the aid beneficiaries.
Ker datumi uveljavitve menjalnega tečaja za nekatere pomoči iz Uredbe (ES) št. 1782/2003 niso bili določeni, je treba določiti enoten datum uveljavitve, neposredno povezan z zahtevki upravičencev.
For the sake of consistency and transparency vis-à-vis the beneficiaries, the operative event should be a date that is as close as possible to the beginning of the payment period introduced under the abovementioned Regulation, and as a way of simplifying checks on the application of the exchange rates and making them more effective, it should precede the beginning of the budget year during which the payments are to be made.
Zaradi doslednosti in preglednosti za upravičence mora biti datum uveljavitve čim bližje začetku plačilnega obdobja, ki je bilo uvedeno z navedeno uredbo; zaradi poenostavitve in učinkovitosti nadzora uporabe menjalnih tečajev pa bi moral biti ta datum pred začetkom proračunskega leta, med katerim morajo biti plačila izvršena.
As a consequence, the operative event for the exchange rate for all aid measures under Regulation (EC) No 1782/2003 should be set uniformly by amending Commission Regulation (EC) No 2808/98 of 22 December 1998 laying down detailed rules for the application of the agrimonetary system for the euro in agriculture [3], and all existing provisions on operative events in the Regulations implementing Regulation (EC) No 1782/2003 should accordingly be repealed.
Zato je treba poenotiti datum uveljavitve menjalnega tečaja za vse pomoči, ki izhajajo iz področja uporabe Uredbe (ES) št. 1782/2003, s spremembo Uredbe Komisije (ES) št. 2808/98 z dne 22. decembra 1998 o določitvi podrobnih pravil za uporabo kmetijsko-monetarnega sistema za evro v kmetijstvu [3], in posledično črtati vse obstoječe določbe, ki se nanašajo na datume uveljavitve iz izvedbenih predpisov Uredbe (ES) št. 1782/2003.
In order to inform operators of the amendments to the Regulations in sufficient time before payments start, this Regulation should apply from 1 August 2005.
Da bi bili nosilci dejavnosti obveščeni o spremembah predpisov dovolj zgodaj pred začetkom izplačil, je treba tudi določiti, da se ta uredba uporablja od 1. avgusta 2005 dalje.
Lastly, as some operative events for 2005 have already been set as a date prior to 1 August 2005, as a transitional measure those operative events should remain applicable for 2005.
Ker so bili nekateri datumi uveljavitve za leto 2005 že določeni na datum pred 1. avgustom 2005, je treba tudi določiti, da ti datumi uveljavitve za leto 2005 ostanejo v uporabi.
Regulation (EC) No 2808/98 and Commission Regulation (EC) No 1973/2004 of 29 October 2004 laying down detailed rules for the application of Council Regulation (EC) No 1782/2003 as regards the support schemes provided for in Titles IV and IVa of that Regulation and the use of land set aside for the production of raw materials [4] should therefore be amended.
Uredbo (ES) št. 2808/98 je zato treba spremeniti, enako tudi Uredbo Komisije (ES) št. 1973/2004 z dne 29. oktobra 2004 o določitvi podrobnih pravil za izvajanje Uredbe Sveta (ES) št. 1782/2003 v zvezi s shemami podpor, iz naslova IV in IVa navedene uredbe, glede uporabe zemljišč v prahi za proizvodnjo surovin [4].
Article 4 of Regulation (EC) No 2808/98 is hereby amended as follows:
Člen 4 Uredbe (ES) št. 2808/98 se spremeni:
For the support schemes listed in Annex I to Council Regulation (EC) No 1782/2003, the operative event for the exchange rate shall be 1 October of the year in respect of which the aid is granted.
Za sheme podpor iz Priloge I k Uredbi Sveta (ES) št. 1782/2003 je datum uveljavitve za menjalni tečaj 1. oktober leta, za katerega je pomoč dodeljena.
For the purposes of applying paragraph 2, the exchange rate to be used shall be the average of the exchange rates applicable during the month preceding the date of the operative event, calculated pro rata temporis.
Menjalni tečaj, ki se ga za namen odstavka 2 uporabi, je enak povprečju menjalnih tečajev, izračunanem po načelu časovnega sorazmerja za mesec pred datumom uveljavitve.
The average of the exchange rates shall be determined by the Commission during the month following the date of the operative event.’
Povprečje menjalnih tečajev določi Komisija v mesecu, ki sledi datumu uveljavitve.“
Article 21(3) and Articles 86 and 128 of Regulation (EC) No 1973/2004 concerning the determination of the operative event for the exchange rate and/or the rules for calculating the exchange rate for aid for starch potatoes, the premiums for sheep and goats and payments involving beef are hereby repealed.
Členi 21(3), 86 in 128 Uredbe (ES) št. 1973/2004, ki se nanašajo na določitev datuma uveljavitve menjalnega tečaja in/ali na pravila izračuna menjalnega tečaja za pomoč za škrobni krompir, premije za ovce in koze ter plačila za govedino in teletino, se črtajo.
It shall apply from 1 August 2005.
Uporabljati se začne 1. avgusta 2005.
However, in the case of the support schemes listed in Annex I to Regulation (EC) No 1782/2003 for which the operative event for the exchange rates for 2005 has been set as a date prior to 1 August 2005, the operative event thus determined shall remain applicable for 2005.
Vendar pa za sheme podpor iz Priloge I k Uredbi (ES) št. 1782/2003, za katere je bil datum uveljavitve menjalnega tečaja za leto 2005 določen na datum pred 1. avgustom 2005, tako opredeljen datum uveljavitve ostane v uporabi za leto 2005.
Regulation as last amended by Commission Regulation (EC) No 394/2005 (OJ L 63, 10.3.2005, p. 17).
Uredba, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 394/2005 (UL L 63, 10.3.2005, str. 17).
Regulation as last amended by Regulation (EC) No 794/2005 (OJ L 134, 27.5.2005, p. 6).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 794/2005 (UL L 134, 27.5.2005, str. 6).
OJ L 270, 21.10.2003, p. 1.’;
UL L 270, 21.10.2003, str. 1.“
Commission Regulation (EC) No 1045/2005
Uredba Komisije (ES) št. 1045/2005
amending Regulation (EC) No 2760/98 concerning the implementation of a programme for cross-border cooperation in the framework of the Phare programme
o spremembi Uredbe (ES) št. 2760/98 o izvajanju programa o čezmejnem sodelovanju v okviru programa PHARE
Having regard to Council Regulation (EEC) No 3906/89 of 18 December 1989 on economic aid to certain countries of central and eastern Europe [1], and in particular Article 8 thereof,
ob upoštevanju Uredbe Sveta (EGS) št. 3906/89 z dne 18. decembra 1989 o gospodarski pomoči nekaterim državam srednje in vzhodne Evrope [1] in zlasti člena [8] Uredbe,
The European Council decided at its meeting in Brussels on 17 and 18 June 2004 that Croatia shall be a candidate country for membership, and requested the Commission to prepare a pre-accession strategy for Croatia, including the necessary instruments,
Evropski svet je na zasedanju v Bruslju 17. in 18. junija 2004 sklenil, da je Hrvaška kandidatka za članstvo, in zaprosil Komisijo, naj za Hrvaško pripravi predpristopno strategijo, vključno s potrebnimi instrumenti.
Council Regulation (EC) No 2257/2004 included Croatia among the beneficiary countries of the Phare pre-accession instrument as of 2 January 2005,
Uredba Sveta (ES) št. 2257/2004 je Hrvaško z 2. januarjem 2005 vključila med države upravičenke predpristopnega instrumenta PHARE.
Commission Regulation (EC) No 2760/98 [2] should, therefore, be amended to extend the Phare cross-border co-operation programme to include the Croatian borders with neighbouring countries,
Uredbo Komisije (ES) št. 2760/98 [2] je zato treba spremeniti, da bo program o čezmejnem sodelovanju PHARE obsegal meje Hrvaške s sosednjimi državami.
The measures provided for in this Regulation are in accordance with the opinion of the Committee for Economic Restructuring in certain countries of central and eastern Europe,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Odbora za gospodarsko prestrukturiranje v nekaterih državah srednje in vzhodne Evrope –
At the end of Article 2(1) of Regulation (EC) No 2760/98, the following text shall be added:
Na koncu odstavka 1 člena 2 Uredbe (ES) št. 2760/98 se doda naslednje:
Croatia and Italy, Croatia and Slovenia, Croatia and Hungary, Croatia and Serbia and Montenegro, Croatia and Bosnia and Herzegovina.’
Hrvaška in Italija, Hrvaška in Slovenija, Hrvaška in Madžarska, Hrvaška in Srbija in Črna gora, Hrvaška in Bosna in Hercegovina“.
OJ L 345, 19.12.1998, p. 49.
UL L 345, 19.12.1998, str. 49.
Regulation as last amended by Regulation (EC) No 1822/2003 (OJ L 267, 17.10.2003, p. 9).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 (UL L 267, 17.10.2003, str. 9).
Commission Regulation (EC) No 1046/2005
Uredba Komisije (ES) št. 1046/2005
amending Regulation (EC) No 958/2003 laying down detailed rules for the application of Council Decision 2003/286/EC as regards the concessions in the form of Community tariff quotas on certain cereal products originating in the Republic of Bulgaria and amending Regulation (EC) No 2809/2000
o spremembi Uredbe (ES) št. 958/2003 o podrobnih pravilih za uporabo Sklepa Sveta 2003/286/ES glede koncesij v obliki tarifnih kvot Skupnosti za nekatere žitne proizvode s poreklom iz Republike Bolgarije in o spremembi Uredbe (ES) št. 2809/2000
Having regard to Council Decision 2003/286/EC of 8 April 2003 on the conclusion of a Protocol adjusting the trade aspects of the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Bulgaria, of the other part, to take account of the outcome of negotiations between the Parties on new mutual agricultural concessions [1], and in particular Article 3(2) thereof,
ob upoštevanju Sklepa Sveta 2003/286/ES z dne 8. aprila 2003 o sklenitvi protokola o prilagoditvi trgovinskih vidikov Evropskega sporazuma o pridružitvi med Evropskimi skupnostmi in njihovimi državami članicami na eni strani ter Republiko Bolgarijo na drugi zaradi upoštevanja rezultatov pogajanj med pogodbenicama o novih vzajemnih kmetijskih koncesijah [1] in zlasti člena 3(2) Sklepa,
Having regard to the Council and Commission Decision 2005/430/EC, Euratom of 18 April 2005 on the conclusion of an Additional Protocol to the Europe Agreement establishing an association between the European Communities and their Member States, of the one part, and the Republic of Bulgaria, of the other part, to take account of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic to the European Union [2], and in particular Article 2 thereof,
ob upoštevanju Sklepa Sveta in Komisije 2005/430/ES z dne 18. aprila 2005 o sklenitvi Dodatnega protokola k Evropskemu sporazumu o pridružitvi med Evropskimi skupnostmi in njihovimi državami članicami na eni strani in Republiko Bolgarijo na drugi strani zaradi upoštevanja pristopa Češke republike, Republike Estonije, Republike Ciper, Republike Latvije, Republike Litve, Republike Madžarske, Republike Malte, Republike Poljske, Republike Slovenije in Slovaške republike [2] in zlasti člena 2 Sklepa,
By Decision 2003/286/EC the Community undertook to establish nil duty import tariff quotas for wheat, meslin and wheat gluten and for maize from Bulgaria.
V skladu s Sklepom 2003/286/ES je Skupnost uvedla uvozne tarifne kvote po stopnji dajatve nič za pšenico, soržico in pšenični gluten ter koruzo iz Bolgarije.
For the 2003/2004 marketing year the volumes of these were set at 250000 tonnes and 80000 tonnes respectively.
Za tržno leto 2003/2004 so bile te kvote 250000 ton in 80000 ton.
Commission Regulation (EC) No 958/2003 [3] sets rules for managing the tariff quotas.
Uredba Komisije (ES) št. 958/2003 [3] je določila načine uporabe glede upravljanja tarifnih kvot.
By Decision 2005/430/EC, Euratom the Community has undertaken to increase the wheat, meslin and wheat gluten quota to 352000 tonnes from 1 July 2005, with a yearly increase of 32000 tonnes.
V skladu s Sklepom 2005/430/ES se je Skupnost odločila z dne 1. julija 2005 povečati uvozno tarifno kvoto po stopnji dajatve nič za pšenico, soržico in pšenični gluten s poreklom iz Bolgarije na 352000 ton in z letno rastjo 32000 ton.
Annex I to Regulation (EC) No 958/2003 must therefore be adapted to take account of this increase.
Prilogo I k Uredbi (ES) št. 958/2003 je treba zaradi upoštevanja tega povečanja spremeniti.
Regulation (EC) No 958/2003 should be amended accordingly.
Uredbo Komisije (ES) št. 958/2003 je zato treba ustrezno spremeniti.
The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for cereals,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Upravljalnega odbora za žita –
Annex I to Regulation (EC) No 958/2003 is replaced by the text in the Annex to this Regulation.
Priloga I k Uredbi (ES) št. 958/2003 se nadomesti z besedilom iz Priloge k tej uredbi.
List of products originating in Bulgaria to in Article 1(1) and (2)
Seznam proizvodov s poreklom iz Bolgarije, predvidenih v členu 1, odstavkih 1 in 2
Description of product
Poimenovanje proizvoda
Annual quantity from 1.7.2005 to 30.6.2006 and following years
Letna količina od 1.7.2005 do 30.6.2006 in za naslednja leta
Yearly increase as from 1.7.2006
Letno povečanje od 1.7.2006
Wheat and meslin
Pšenica in soržica
Nil
Nič
Commission Regulation (EC) No 1047/2005
Uredba Komisije (ES) št. 1047/2005
The Community producer and import prices for uniflorous (bloom) carnations, multiflorous (spray) carnations, large-flowered roses and small-flowered roses as referred to in Article 1 of Regulation (EEC) No 4088/87 shall be as set out in the Annex hereto for the period from 6 to 19 July 2005.
Proizvodne in uvozne cene Skupnosti za enocvetne (navadne) nageljne, mnogocvetne (spray) nageljne, velecvetne vrtnice in drobnocvetne vrtnice iz člena 1 Uredbe (EGS) št. 4088/87 so določene v Prilogi sedanje uredbe za obdobje od 6. do 19. julija 2005.
Period from 6 to 19 July 2005
Obdobje: od 6. do 19. julija 2005
Commission Regulation (EC) No 1048/2005
Uredba Komisije (ES) št. 1048/2005
amending Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
o spremembi Uredbe Komisije (ES) št. 2032/2003 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta v zvezi z dajanjem biocidnih proizvodov v promet
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [1], and in particular Article 16(2) thereof,
ob upoštevanju Direktive 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [1] in zlasti člena 16(2) Direktive,
Article 4 of Commission Regulation (EC) No 2032/2003 [2] lays down that, from the date of entry into force, any existing active substance not listed in Annex I to that Regulation is to be considered as not having been placed on the market for biocidal purposes before 14 May 2000.
Člen 4 Uredbe Komisije (ES) št. 2032/2003 [2] določa, da se mora od začetka veljavnosti Uredbe vsaka obstoječa aktivna snov, ki ni navedena v Prilogi I k navedeni uredbi, šteti, kakor da ni bila dana v promet za biocidne namene pred 14. majem 2000.
As a consequence biocidal products containing active substances not listed in Annex I may no longer be placed on the market, unless inclusion into Annex I or IA to Directive 98/8/EC is applied for in accordance with Article 11 of that Directive, and provisional authorisation has been received in accordance with Article 15(2) of that Directive.
Zato se biocidni proizvodi, ki vsebujejo aktivne snovi, ki niso navedene v Prilogi I, ne smejo več dajati v promet, razen če se zaprosi za vključitev v Prilogo I ali IA k Direktivi 98/8/ES v skladu s členom 11 navedene direktive in je bilo izdano začasno dovoljenje v skladu s členom 15(2) navedene direktive.
However, a limited number of active substances have been detected by the Member States which were not identified or notified before the time limit laid down in Commission Regulations (EC) No 1896/2000 [3] and (EC) No 1687/2002 [4] although there is evidence they were contained in biocidal products placed on the market before 14 May 2000.
Vendar so države članice odkrile omejeno število aktivnih snovi, ki niso bile identificirane ali prijavljene pred iztekom roka, določenega v uredbah Komisije (ES) št. 1896/2000 [3] in (ES) št. 1687/2002 [4], čeprav je dokazano, da so bile vsebovane v biocidnih proizvodih, ki so bili dani v promet pred 14. majem 2000.
Some of these active substances are important from a socioeconomic perspective or for protection of public health.
Nekatere od teh aktivnih snovi so pomembne s socialno-ekonomskega vidika ali glede varstva javnega zdravja.
It is therefore appropriate to draw up a further list of active substances that should be allowed to remain on the market until 1 September 2006.
Zato je primerno sestaviti nadaljnji seznam aktivnih snovi, ki smejo ostati v prometu do 1. septembra 2006.
Certain substances not included in Annex II to Regulation (EC) No 2032/2003 are applied in uses for which Member States claim that there is evidence demonstrating the essential need for reasons of health, safety, and protection of cultural heritage, or the use is critical for the functioning of society in the absence of technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment or health.
Nekatere snovi, ki niso vključene v Prilogo II k Uredbi (ES) št. 2032/2003, se uporabljajo za namene, za katere je po mnenju držav članic dokazano, da so nujno potrebni iz zdravstvenih in varstvenih razlogov ter zaradi varovanja kulturne dediščine ali je njihova uporaba odločilnega pomena za delovanje družbe v odsotnosti tehnično in ekonomsko izvedljivih drugih možnosti ali nadomestkov, ki so sprejemljivi z okoljskega ali zdravstvenega vidika.
It is therefore appropriate to introduce a system for applying for an extension of the period for marketing of biocidal products containing those substances.
Zato je primerno, da se uvede sistem, po katerem se bo lahko zaprosilo za podaljšanje obdobja za dajanje v promet biocidnih proizvodov, ki vsebujejo navedene snovi.
Such extensions should only be granted for the requesting Member States if the requests are justified, continued use does not give rise to concerns for human health and the environment, and, where appropriate, alternatives are being developed.
Taka podaljšanja se lahko odobrijo le državam članicam prosilkam, če so zahtevki upravičeni, če dolgoročna uporaba ne škoduje zdravju ljudi in okolju in če se, kadar je to primerno, razvijajo druge možnosti.
The extension should only be allowed until 14 May 2010 at the latest.
Podaljšanje se dovoli največ do 14. maja 2010.
In accordance with Article 4(2) of Regulation (EC) No 2032/2003, placing on the market of biocidal products containing active substances not notified, or not notified for the appropriate product types, has to stop on 1 September 2006 at the latest.
V skladu s členom 4(2) Uredbe (ES) št. 2032/2003 se mora dajanje v promet biocidnih proizvodov, ki vsebujejo aktivne snovi, ki niso bile prijavljene, ali niso bile prijavljene za ustrezne vrste proizvodov, ustaviti najkasneje 1. septembra 2006.
For certain substances or substance/product type combinations that have so far not been notified, there is now an interest by economic operators to prepare complete dossiers in view of their inclusion into Annex I or IA to Directive 98/8/EC.
Gospodarskim subjektom je zdaj v interesu, da bi za nekatere snovi ali kombinacije snovi/vrst proizvodov, ki do sedaj še niso bile prijavljene, pripravili popolne dosjeje z namenom njihove vključitve v Prilogo I ali IA k Direktivi 98/8/ES.