natgillin/translations-raw huggingface dataset:
For reasons of public health and legal consistency, and with a view to reducing the administrative burden and strengthening predictability for economic operators, variations to all types of marketing authorisations should be subject to harmonised rules.
Zaradi javnega zdravja in pravne doslednosti ter z namenom zmanjšanja upravnega bremena in povečanja predvidljivosti za nosilce gospodarskih dejavnosti bi morala za vse vrste dovoljenj za promet veljati usklajena pravila.
The rules on variations adopted by the Commission should pay particular attention to simplifying administrative procedures.
Pravila o spremembah, ki jih je sprejela Komisija, bi se morala zlasti posvetiti poenostavitvi upravnih postopkov.
To this effect, the Commission should provide, when adopting these rules, for the possibility of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations.
Zato bi morala Komisija pri sprejemanju teh pravil predvideti možnost predložitve ene vloge za eno ali več enakih sprememb večjega števila dovoljenj za promet.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [7], Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje [7] se države članice spodbuja, da za svoje potrebe in v interesu Skupnosti izdelajo in objavijo tabele, ki naj, kolikor nazorno je to mogoče, prikažejo korelacijo med to direktivo in ukrepi za prenos v nacionalno pravo.
Directive 2001/82/EC and Directive 2001/83/EC should therefore be amended accordingly,
Direktivi 2001/82/ES in 2001/83/ES bi bilo zato treba ustrezno spremeniti –
Amendments to Directive 2001/82/EC
Spremembi Direktive 2001/82/ES
Directive 2001/82/EC is hereby amended as follows:
Direktiva 2001/82/ES se spremeni:
‘Article 27b
„Člen 27b
The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive.
Komisija sprejme ustrezne dogovore za pregled sprememb pogojev dovoljenja za promet, izdanega v skladu s to direktivo.
The Commission shall adopt these arrangements in the form of an implementing regulation.
Komisija sprejme te dogovore v obliki izvedbene uredbe.
That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 89(2a).’
Ta ukrep, namenjen spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 89(2a).“;
the second and third subparagraphs of Article 39(1) shall be deleted.
v členu 39(1) se drugi in tretji pododstavek črtata.
Amendments to Directive 2001/83/EC
Spremembi Direktive 2001/83/ES
‘Article 23b
„Člen 23b
The Commission shall adopt the arrangements referred to in paragraph 1 in the form of an implementing regulation.
Komisija sprejme dogovore iz odstavka 1 v obliki izvedbene uredbe.
That measure, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).
Ta ukrep, namenjen spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 121(2a).
When adopting the arrangements referred to in paragraph 1, the Commission shall make efforts to make it possible to submit a single application for one or more identical changes made to the terms of a number of marketing authorisations.
Pri sprejemanju dogovorov iz odstavka 1 si Komisija prizadeva za možnost predložitve ene vloge za eno ali več enakih sprememb večjega števila dovoljenj za promet.
A Member State may continue to apply national provisions on variations applicable at the time of entry into force of the implementing regulation to marketing authorisations granted before 1 January 1998 to medicinal products authorised only in that Member State.
Države članice lahko še naprej uporabljajo nacionalne določbe o spremembah, ki veljajo na dan začetka veljavnosti izvedbene uredbe, za dovoljenja za promet, izdana pred 1. januarjem 1998 za zdravila, za katera je bilo izdano dovoljenje le v tej državi članici.
Where a medicinal product subject to national provisions in accordance with this Article is subsequently granted a marketing authorisation in another Member State, the implementing regulation shall apply to that medicinal product from that date.
Kadar se za zdravilo, za katerega veljajo nacionalne določbe v skladu s tem členom, naknadno izda dovoljenje za promet v drugi državi članici, velja zanj od tega datuma naprej izvedbena uredba.
Where a Member State decides to continue to apply national provisions pursuant to paragraph 4, it shall notify the Commission thereof.
Kadar se država članica odloči, da bo še naprej uporabljala nacionalne določbe na podlagi odstavka 4, o tem obvesti Komisijo.
If a notification has not been made by 20 January 2011, the implementing regulation shall apply.’
Če Komisije ne obvesti do 20. januarja 2011, se uporablja izvedbena uredba.“;
the second and third subparagraphs of Article 35(1) shall be deleted.
v členu 35(1) se drugi in tretji pododstavek črtata.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedilo določb predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
OJ C 27, 3.2.2009, p. 39.
UL C 27, 3.2.2009, str. 39.
Opinion of the European Parliament of 22 October 2008 (not yet published in the Official Journal) and Council Decision of 28 May 2009.
Mnenje Evropskega parlamenta z dne 22. oktobra 2008 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 28. maja 2009.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 January 2011 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 20. januarja 2011.
They shall forthwith communicate to the Commission the text thereof.
O tem takoj obvestijo Komisijo.
Directive 2009/54/EC of the European Parliament and of the Council
Direktiva 2008/54/ES Evropskega parlamenta in Sveta
on the exploitation and marketing of natural mineral waters
o izkoriščanju in trženju naravnih mineralnih vod
Having regard to the opinion of the European Economic and Social Committee [1],
ob upoštevanju mnenja Ekonomsko-socialnega odbora [1],
Acting in accordance with procedure laid down in Article 251 of the Treaty [2],
v skladu s postopkom, določenim v členu 251 Pogodbe [2],
Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters [3] has been substantially amended several times [4].
Direktiva Sveta 80/777/EGS z dne 15. julija 1980 o približevanju zakonodaje držav članic o izkoriščanju in trženju naravnih mineralnih vod [3] je bila večkrat bistveno spremenjena [4].
Since further amendments are to be made, it should be recast in the interests of clarity.
Ker so predvidene nove spremembe, bi jo bilo treba zaradi jasnosti prenoviti.
The laws of the Member States define natural mineral waters.
Naravne mineralne vode opredeljujejo zakonodaje držav članic.
Those laws lay down the terms on which natural mineral waters are recognised as such and govern the conditions for exploiting springs.
Te zakonodaje določajo pogoje, pod katerimi se naravne mineralne vode priznavajo kot takšne in urejajo pogoje za izkoriščanje izvirov.
They furthermore prescribe specific rules for marketing the waters in question.
Vsebujejo tudi posebne predpise za trženje zadevnih vod.
The differences between those laws hinder the free movement of natural mineral waters, creating disparate competitive situations, and consequently directly affect the functioning of the internal market.
Razlike med temi zakonodajami ovirajo prosti pretok naravnih mineralnih vod in ustvarjajo neenake konkurenčne razmere ter kot posledica tega neposredno vplivajo na delovanje notranjega trga.
In this particular case, the elimination of these barriers may be achieved both by an obligation on each Member State to allow the marketing in its territory of the natural mineral waters recognised as such by each of the other Member States and by laying down common rules concerning in particular the microbiological requirements to be fulfilled and the conditions in which specific names must be used for certain of the mineral waters.
V obravnavanem primeru se odstranitev ovir lahko doseže z obveznostjo vsake države članice, da na svojem ozemlju dovoli trženje z mineralnimi vodami, ki jih vsaka druga država članica priznava kot naravne mineralne vode, in z določitvijo skupnih predpisov zlasti glede mikrobioloških zahtev, ki jih morajo izpolnjevati, in glede posebnih imen, ki se uporabljajo za nekatere mineralne vode.
The primary purposes of any rules on natural mineral waters should be to protect the health of consumers, to prevent consumers from being misled and to ensure fair trading.
Varovanje zdravja potrošnikov, preprečevanje njihovega zavajanja in zagotovitev poštenega trgovanja bi morali biti glavni nameni vseh pravil o naravnih mineralnih vodah.
Pending the conclusion of agreements on mutual recognition of natural mineral waters between the Community and third countries, the terms should be laid down on which, until implementation of those agreements, similar products imported from third countries may be allowed to enter the Community as natural mineral waters.
Do sklenitve sporazumov o vzajemnem priznavanju naravnih mineralnih vod med Skupnostjo in tretjimi državami bi bilo treba določiti pogoje, pod katerimi so podobni proizvodi, uvoženi iz tretjih držav, do izvajanja navedenih sporazumov lahko v Skupnosti priznani kot naravne mineralne vode.
Care should be taken to ensure that natural mineral waters retain at the marketing stage those characteristics which enabled them to be recognised as such.
Morali bi si prizadevati, da naravne mineralne vode na stopnji trženja ohranijo značilnosti, ki upravičujejo njihovo priznavanje za naravne mineralne vode.
Therefore, the containers used for packaging them should have suitable closures.
Zato bi morala imeti embalaža za polnjenje ustrezno zapiranje.
In respect of labelling, natural mineral waters are subject to the general rules laid down by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [5].
Za označevanje naravnih mineralnih vod veljajo splošna pravila iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [5].
Accordingly, this Directive may be limited to laying down the additions and derogations which should be made to those general rules.
Zato bi bilo treba v tej direktivi določiti samo dopolnitve in odstopanja od navedenih splošnih pravil.
The inclusion of the statement of the analytical composition of a natural mineral water should be compulsory in order to ensure that consumers are informed.
Navedba kemijske sestave naravne mineralne vode na označbi bi morala biti obvezna, da se zagotovi obveščenost potrošnikov.
In particular, the Commission should be empowered to adopt limits for the concentrations of constituents of natural mineral waters, any necessary provisions for the indication on the labelling of high levels of certain constituents, the conditions of use of ozone-enriched air for the treatment of natural mineral water, information on the treatments of natural mineral water, methods of analysis to determine the absence of pollution of natural mineral waters, and the sampling procedures and methods of analysis necessary for checking the microbiological characteristics of natural mineral waters.
Zlasti bi bilo treba Komisiji podeliti pooblastila za sprejetje mejnih vrednosti koncentracij sestavin naravnih mineralnih vod, vseh potrebnih določb glede navedb o visoki vsebnosti nekaterih sestavin na označbi, pogojev za uporabo zraka, obogatenega z ozonom, navedb o obdelavi naravnih mineralnih vod, analiznih metod za določitev odsotnosti nečistoč v naravnih mineralnih vodah ter postopkov vzorčenja in analiznih metod, potrebnih za nadzor mikrobioloških lastnosti naravnih mineralnih vod.
Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te direktive, vključno z njenim dopolnjevanjem, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to this Directive necessary in order to ensure the protection of public health.
Kadar v nujnih primerih ni mogoče upoštevati običajnih rokov za regulativni postopek s pregledom, bi bilo treba Komisiji omogočiti uporabo nujnega postopka iz člena 5a(6) Sklepa 1999/468/ES, za sprejetje sprememb te direktive, potrebnih za zagotovitev varovanja javnega zdravja.
They therefore do not need to be transposed by the Member States.
Zato jih državam članicam ni potrebno prenesti v nacionalni pravni red.
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex IV, Part B,
Ta direktiva ne bi smela posegati v obveznosti držav članic v zvezi z roki za prenos v nacionalno pravo direktiv, navedenimi v delu B Priloge IV –
This Directive concerns waters extracted from the ground of a Member State and recognised by the responsible authority of that Member State as natural mineral waters satisfying the provisions of Annex I, Section I.
Ta direktiva se nanaša na vode, pridobljene iz tal države članice in ki jih je pristojni organ te države članice priznal kot naravne mineralne vode, ki izpolnjujejo določbe oddelka I Priloge I.
This Directive also concerns waters extracted from the ground of a third country, imported into the Community and recognised as natural mineral waters by the responsible authority of a Member State.
Ta direktiva se nanaša tudi na vode, pridobljene iz tal tretje države, ki so uvožene v Skupnost in jih je pristojni organ države članice priznal kot naravne mineralne vode.
The waters referred to in the first subparagraph may be so recognised only if the responsible authority in the country of extraction has certified that they satisfy the provisions of Annex I, Section I, and that regular checks are made on the application of the provisions of Annex II, point 2.
Vode iz prvega pododstavka se lahko priznajo samo, če je pristojni organ države, kjer je voda pridobljena, potrdil, da izpolnjujejo določbe oddelka I Priloge I in da se redno preverja skladnost z določbami iz točke 2 Priloge II.
The validity of the certification referred to in the second subparagraph may not exceed a period of five years.
Potrdilo iz drugega pododstavka velja največ pet let.
It shall not be necessary to repeat the recognition procedure referred to in the first subparagraph if the certification is renewed before the end of that period.
Postopka priznavanja iz prvega pododstavka ni treba ponoviti, če se potrdilo obnovi pred potekom navedenega roka.
This Directive shall not apply to:
Ta direktiva se ne uporablja:
waters which are medicinal products within the meaning of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [7];
za vode, ki so zdravilo v smislu Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [7];
natural mineral waters used at source for curative purposes in thermal or hydromineral establishments.
za naravne mineralne vode, ki se na izviru uporabljajo v zdravilne namene v naravnih zdraviliščih in termah.
The grounds for granting the recognition referred to in paragraphs 1 and 2 shall be stated in due form by the responsible authority of the Member State and shall be officially published.
Razloge za priznavanje iz odstavkov 1 in 2 pristojni organ države članice v predpisani obliki utemelji in uradno objavi.
Each Member State shall inform the Commission of the cases where the recognition referred to in paragraphs 1 and 2 has been granted or withdrawn.
Vsaka država članica Komisijo obvesti o primerih, v katerih priznavanje iz odstavkov 1 in 2 podeli ali prekliče.
The list of natural mineral waters so recognised shall be published in the Official Journal of the European Union.
Seznam vod, priznanih kot naravne mineralne vode, se objavi v Uradnem listu Evropske unije.
Member States shall take the measures necessary to ensure that only the waters referred to in Article 1 which comply with the provisions of this Directive may be marketed as natural mineral waters.
Države članice sprejmejo potrebne ukrepe za zagotovitev, da se samo vode iz člena 1, ki so v skladu z določbami te direktive, tržijo kot naravne mineralne vode.
Natural mineral water springs may be exploited and their waters bottled only in accordance with Annex II.
Izviri naravnih mineralnih vod se lahko izkoriščajo in njihova voda polni samo v skladu s Prilogo II.
Natural mineral water, in its state at source, may not be the subject of any treatment other than:
Naravne mineralne vode se na izviru ne sme obdelati z nobenim postopkom, razen:
the separation of its unstable elements, such as iron and sulphur compounds, by filtration or decanting, possibly preceded by oxygenation, in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties;
z izločanjem njenih neobstojnih sestavin, kakor so železove in žveplove spojine, s postopkom filtracije ali dekantiranja, ki lahko vključuje tudi postopek poprejšnje oksidacije, če takšen postopek ne spremeni sestave vode glede njenih značilnih sestavin;
the separation of iron, manganese and sulphur compounds and arsenic from certain natural mineral waters by treatment with ozone-enriched air in so far as such treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that:
z izločanjem železovih, manganovih in žveplenih spojin in arzena iz nekaterih mineralnih vod z uporabo zraka, obogatenega z ozonom, če takšen postopek ne spremeni sestave vode glede njenih značilnih sestavin in če:
the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [8];
je obdelava v skladu s pogoji uporabe, ki jih določi Komisija po posvetovanju z Evropsko agencijo za varnost hrane, ki je bila ustanovljena z Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [8];
the treatment is notified to, and specifically controlled by, the competent authorities;
so o obdelavi obveščeni pristojni organi, ki obdelavo tudi posebej nadzirajo;
the separation of undesirable constituents other than those specified in points (a) or (b), in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that:
z izločanjem drugih nezaželenih sestavin, razen tistih, navedenih v točkah (a) in (b), če takšen postopek ne spremeni sestave vode glede njenih značilnih sestavin in če:
the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority;
je obdelava v skladu s pogoji uporabe, ki jih določi Komisija po posvetovanju z Evropsko agencijo za varnost hrane;
the total or partial elimination of free carbon dioxide by exclusively physical methods.
s popolnim ali delnim odvzemom prostega ogljikovega dioksida z izključno fizikalnimi postopki.
The measures referred to in points (b)(i) and (c)(i), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).
Ukrepi iz točk (b)(i) in (c)(i), namenjeni spreminjanju nebistvenih določb te direktive z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(2).
The first subparagraph shall not constitute a bar to the utilisation of natural mineral waters and spring waters in the manufacture of soft drinks.
Prvi pododstavek ni ovira za uporabo mineralnih in izvirskih vod pri proizvodnji brezalkoholnih osvežilnih pijač.
Natural mineral water, in its state at source, may not be the subject of any addition other than the introduction or the reintroduction of carbon dioxide under the conditions laid down in Annex I, Section III.
Naravni mineralni vodi, kakršna obstaja na izviru, se ne sme dodajati ničesar, razen uvajanja ali ponovnega uvajanja ogljikovega dioksida pod pogoji, določenimi v oddelku III Priloge I.
Any disinfection treatment by whatever means and, subject to paragraph 2, the addition of bacteriostatic elements or any other treatment likely to change the viable colony count of the natural mineral water, shall be prohibited.
Prepovedano je kakršno koli razkuževanje s kakršnimi koli sredstvi kot tudi, ob upoštevanju odstavka 2, dodajanje bakteriostatičnih sredstev in kakršen koli postopek obdelave, ki bi lahko spremenil število mikroorganizmov, sposobnih za razmnoževanje.
The revivable total colony count of a natural mineral water at source shall conform to its normal viable colony count and give satisfactory evidence of the protection of the source against all contamination.
Skupno število mikroorganizmov, sposobnih za razmnoževanje, v naravni mineralni vodi na izviru ustreza običajnemu številu mikroorganizmov, sposobnih za razmnoževanje, kar dokazuje, da je izvir zaščiten pred vsakršno kontaminacijo.
This total colony count shall be determined under the conditions laid down in Annex I, Section II, point 1.3.3.
Skupno število mikroorganizmov, sposobnih za razmnoževanje, se določi v skladu s pogoji iz točke 1.3.3 oddelka II Priloge I.
After bottling, the total colony count at source may not exceed 100 per millilitre at 20 to 22 °C in 72 hours on agar-agar or an agar-gelatine mixture and 20 per millilitre at 37 °C in 24 hours on agar-agar.
Po polnjenju skupno število mikroorganizmov, sposobnih za razmnoževanje, na izviru ne sme presegati 100 na mililiter pri 20 do 22 °C in 72-urni inkubaciji na hranljivem agarju ali želatinasti mešanici in 20 na mililiter pri 37 °C in 24-urni inkubaciji na hranljivem agarju.
The total colony count shall be measured within the 12 hours following bottling, the water being maintained at 4 °C ± 1 °C during this 12-hour period.
Skupno število mikroorganizmov, sposobnih za razmnoževanje, se meri 12 ur po polnjenju, pri čemer se v tem 12-urnem obdobju ohranja temperatura vode pri 4 °C ± 1 °C.