natgillin/translations-raw huggingface dataset:
ob upoštevanju poročila Odbora za promet in turizem ( A6-0178/2008 ),
having regard to the report of the Committee on Transport and Tourism ( A6-0178/2008 ),
ker po mnenju posvetovalne delovne skupine pravnih služb Evropskega parlamenta, Sveta in Komisije zadevni predlog ne predvideva bistvenih sprememb, razen tistih, ki so v njem opredeljene kot take, in ker je ta predlog, kar zadeva kodifikacijo nespremenjenih določb prejšnjih aktov skupaj z omenjenimi spremembami, zgolj kodifikacija obstoječih besedil brez vsebinskih sprememb,
whereas, according to the Consultative Working Party of the Legal Services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts without any change in their substance,
(Ker je bil dosežen sporazum med Parlamentom in Svetom, je stališče Parlamenta iz prve obravnave enako končnemu zakonodajnemu aktu, Direktivi 2008/106/ES.)
(As an agreement was reached between Parliament and Council, Parliament's position at first reading corresponds to the final legislative act, Directive 2008/106/EC.)
Zakonodajna resolucija Evropskega parlamenta z dne 17. junija 2008 o predlogu Uredbe Evropskega parlamenta in Sveta o določitvi postopkov Skupnosti za določitev vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe (EGS) št. 2377/90 ( KOM(2007)0194 – C6-0113/2007 – 2007/0064(COD) )
European Parliament legislative resolution of 17 June 2008 on the proposal for a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90 ( COM(2007)0194 – C6-0113/2007 – 2007/0064(COD) )
ob upoštevanju predloga Komisije Evropskemu parlamentu in Svetu ( KOM(2007)0194 ),
having regard to the Commission proposal to the European Parliament and the Council ( COM(2007)0194 ),
ob upoštevanju člena 251(2) ter členov 37 in 152(4)(b) Pogodbe ES, na podlagi katerih je Komisija Parlamentu podala predlog ( C6-0113/2007 ),
having regard to Article 251(2) and Articles 37 and 152(4)(b) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament ( C6-0113/2007 ),
ob upoštevanju poročila Odbora za okolje, javno zdravje in varnost hrane ter mnenja Odbora za kmetijstvo in razvoj podeželja ( A6-0190/2008 ),
having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Agriculture and Rural Development ( A6-0190/2008 ),
UL C 10, 15.1.2008, str.
OJ C 10, 15.1.2008, p.
ob upoštevanju mnenja Odbora regij UL C ...
Having regard to the opinion of the Committee of the Regions OJ C ...
Stališče Evropskega parlamenta z dne 17. junija 2008.
Position of the European Parliament of 17 June 2008
Zaradi znanstvenega in tehničnega napredka je mogoče odkriti prisotnost ostankov veterinarskih zdravil v živilih na vedno nižji ravni.
As a result of scientific and technical progress it is possible to detect the presence of residues of veterinary medicines in foodstuffs at ever lower levels.
Kljub postopku iz členov 10 in 11 Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini
Despite the existence of the procedure laid down in Articles 10 and 11 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
(imenovanem 'kaskadni postopek'), s katerim bi se omogočilo zdravljenje živali v primerih, ko ni dovoljenega zdravila za uporabo v veterinarski medicini, v Evropski uniji še vedno obstaja mnogo terapevtskih potrebam po zdravilih za uporabo v veterinarski medicini.
(the "cascade" procedure) to enable the treatment of animals where there is no suitable veterinary medicine authorised, there remain many unmet therapeutic needs for veterinary medicinal products in the European Union.
Prav tako je treba posebno pozornost nameniti skrbi za posebnosti sektorja zdravja živali v Evropski uniji, pri katerem gre za večvrsten, kompleksen in pogosto omejen trg, ki pa je ključnega pomena za uresničitev potenciala kmetijstva, čebelarstva, ribogojstva in vzreje čistokrvnih konj ter za zanesljivost oskrbe EU s hrano.
Particular care must also be taken to cater for the specificities of the animal health sector in the EU, as it is a multi-species, complex, and often limited market which is nonetheless vital to the realisation of the potential of the agriculture, apiculture, aquaculture and bloodstock sectors and to the security of the EU food supplies.
Za varovanje zdravja ljudi bi bilo treba v skladu s splošno priznanimi načeli presoje varnosti določiti najvišje mejne vrednosti ostankov in pri tem upoštevati toksikološka tveganja, okoljsko onesnaženost ter nenamerne mikrobiološke in farmakološke učinke ostankov.
In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamination, as well as unintended microbiological and pharmacological effects of residues.
so bili uvedeni postopki Skupnosti za oceno varnosti ostankov farmakološko aktivnih snovi v skladu z zahtevami glede varnosti živil.
introduced Community procedures to evaluate the safety of residues of pharmacologically active substances according to human food safety requirements.
Farmakološko aktivna snov se lahko uporablja pri živalih za proizvodnjo živil samo, če je bila ocena ugodna.
A pharmacologically active substance may be used in food-producing animals only if evaluated favourably.
Mejne vrednosti ostankov za tako snov se določijo, če se zdi to potrebno za varovanje zdravja ljudi.
Maximum residue limits are established for such a substance if that is considered necessary for the protection of human health.
resolucije Evropskega parlamenta z dne 3. maja 2001
European Parliament's resolution of 3 May 2001
UL C 27 E, 31.1.2002, str.
OJ C 27 E, 31.1.2002, p.
o dostopnosti zdravil za uporabo v veterinarski medicini,
on the availability of veterinary medicinal products, the
javnega posvetovanja Komisije leta 2004 in Komisijine ocene pridobljenih izkušenj se zdi potrebno spremeniti postopke za določitev mejnih vrednosti ostankov ter hkrati ohraniti splošen sistem določanja teh vrednosti.
Commission's public consultation undertaken in 2004 and the Commission's assessment of the experience gained, it has proved necessary to modify the procedures for setting maximum residue limits while maintaining the overall system for setting such limits.
z dne 29. aprila 1996
of 29 April 1996
o prepovedi uporabe v živinoreji določenih snovi, ki imajo hormonalno ali tirostatično delovanje, in beta-agonistov ║ UL L 125, 23.5.1996, str.
concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists ║ OJ L 125, 23.5.1996, p.
prepoveduje uporabo nekaterih snovi za posebne namene pri živalih za proizvodnjo živil.
prohibits the use of certain substances for specific purposes in food-producing animals.
določa posebna pravila za snovi, ki niso posledica namenskega dajanja.
lays down specific rules for substances not resulting from intentional administration.
Navedene snovi ne smejo biti predmet zakonodaje o mejnih vrednostih ostankov.
Those substances should not be subject to the legislation on maximum residue limits.
Evropskega parlamenta in Sveta z dne 28. januarja 2002
of the European Parliament and of the Council of 28 January 2002
o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane UL L 31, 1.2.2002, str.
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 OJ L 31, 1.2.2002, p.
določa okvir za zakonodajo na področju hrane na ravni Skupnosti in predvideva opredelitve na navedenem področju.
lays down the framework for food legislation on a Community level and provides for definitions in that area.
določa splošna pravila za nadzor hrane v Evropski skupnosti in zagotavlja opredelitve na navedenem področju.
lays down general rules for the control of food in the European Community and provides for definitions in that area.
Prednost je treba dati odkrivanju uporabe prepovedanih snovi, del vzorcev pa bi bilo treba izbrati na podlagi načel analize tveganja.
Priority should be given to the detection of the use of prohibited substances and part of the samples should be selected according to risk analysis principles
Člen 57 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila UL L 136, 30.4.2006, str.
Article 57 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency OJ L 136, 30.4.2006, p.
Poleg tega lahko pomanjkanje dostopnosti ustreznega zdravila za uporabo v veterinarski medicini za posebno zdravljenje posebnih vrst privede do zlorabe ali nezakonite uporabe snovi.
Furthermore, the lack of availability of appropriate veterinary medicinal products for a specific treatment for a specific species may contribute to the misuse or illegal use of substances.
Za doseganje navedenega cilja bi bilo treba sprejeti določbo, po kateri bi Agencija sistematično proučila uporabo mejne vrednosti ostankov, določene za eno vrsto ali živilo, za drugo vrsto ali drugo živilo.
In order to serve that objective, provision should be made for the systematic consideration by the Agency of the use of a maximum residue limit established for one species or foodstuff for another species or another foodstuff.
bi morala zato dati mnenje o znanstveni oceni tveganja in priporočila o obvladovanju tveganj pri ostankih farmakološko aktivnih snovi.
Agency should therefore provide an opinion on the scientific risk assessment and risk management recommendations on residues of pharmacologically active substances.
Poleg tega se lahko zdravila za uporabo v veterinarski medicini brez dovoljenja za promet v Skupnosti odobrijo v državah zunaj Skupnosti.
Further, veterinary medicinal products not having a marketing authorisation in the Community may be authorised in countries outside the Community.
To je mogoče, ker v drugih regijah bolj prevladujejo druge bolezni ali ciljne vrste ali ker so se družbe odločile, da proizvoda v Skupnosti ne bodo dale v promet.
That may be because in other regions different diseases or target species are more prevalent or because companies have chosen not to market a product in the Community.
Dejstvo, da proizvod v Skupnosti ni odobren, ne pomeni nujno, da je njegova uporaba nevarna.
The fact that a product is not authorised in the Community does not necessarily indicate that its use is unsafe.
Za farmakološko aktivne snovi takšnih proizvodov bi moralo biti Komisiji omogočeno določanje mejnih vrednosti ostankov za živila, in sicer na podlagi mnenja Agencije v skladu z načeli za farmakološko aktivne snovi, namenjene za uporabo v zdravilih za uporabo v veterinarski medicini.
For the pharmacologically active substances of such products, the Commission should be enabled to set a maximum residue limit for food, following an opinion by the Agency in accordance with the principles set for pharmacologically active substances intended for use in veterinary medicinal products.
Tudi če vrednosti ostankov za takšne snovi niso določene v skladu s to uredbo, se lahko ostanki takšnih snovi pojavijo zaradi okoljske onesnaženosti ali pojava naravnega metabolita v živalih.
Even if residue limits are not set for such substances pursuant to this Regulation, residues of such substances might occur due to environmental contamination or occurrence of a natural metabolite in the animal.
Z laboratorijskimi metodami je mogoče ugotoviti takšne ostanke na vedno nižjih ravneh.
Laboratory methods are capable of finding such residues at ever lower levels.
Takšni ostanki so privedli do različnih nadzornih praks v državah članicah.
Such residues have caused different control practices in Member States.
brez ogrožanja visoke ravni varovanja zdravja ljudi v Skupnosti.
without undermining a high level of human health protection in the Community.
Vendar določitev referenčnih točk za nadzor nikakor ne bi smela služiti kot izgovor za toleriranje nezakonite uporabe neodobrenih snovi pri zdravljenju živali za proizvodnjo živil.
However, the setting of reference points for control action should in no way serve as a pretext for condoning the illegal use of non-authorised substances to treat food-producing animals.
Zato je treba vse ostanke teh snovi v živilih obravnavati kot nezaželene.
Therefore, any residues of those substances in food must be considered undesirable
Zlasti je treba
In particular,
pooblastila za sprejemanje pravil o pogojih ekstrapolacije in o vzpostavitvi referenčnih točk za ukrepe.
to adopt rules on the conditions for extrapolation and on the establishment of reference points for action.
Ker so navedeni ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe
Since those measures are of general scope and are designed to amend non-essential elements of this Regulation,
doseže na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti, kot je določeno v členu 5 Pogodbe.
, namely to protect human health as well as animal health, and to ensure the availability of appropriate veterinary medicinal products, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Zagotoviti je treba prehodno obdobje, da se Komisiji omogoči priprava in sprejetje uredbe, ki vsebuje vse veljavne odločitve v skladu z Uredbo
A transitional period should be provided for in order to allow the Commission to prepare and adopt a regulation which contains all applicable decisions pursuant to Regulation
2377/90 in izvedbenimi določbami za to novo uredbo –
2377/90 and implementing provisions for this new regulation,
Za zagotavljanje varnosti hrane
For the purpose of ensuring food safety,
uredba določa pravila in postopke za določitev:
Regulation lays down rules and procedures in order to establish the following:
ravni ▌ostanka farmakološko aktivne snovi,
the ▌ level of a residue of a pharmacologically active substance
določene zaradi nadzora v primeru nekaterih snovi, za katere mejna vrednost ostanka ni določena v skladu s to uredbo
, established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation
učinkovine biološkega izvora, namenjene ustvarjanju aktivne ali pasivne imunosti ali ugotavljanju stanja imunosti, ki se uporabljajo v imunoloških zdravilih za uporabo v veterinarski medicini;
active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;
Ta uredba se uporablja ne glede na zakonodajo Skupnosti o prepovedi uporabe nekaterih snovi s hormonalnim delovanjem pri živalih za proizvodnjo živil, kot določa Direktiva 96/22/ES.
This regulation shall apply without prejudice to Community legislation prohibiting the use in food producing animals of certain substances having a hormonal action as provided by Directive 96/22/EC.
Poleg opredelitev iz člena 1 Direktive 2001/82/ES, člena 2 Uredbe (ES) št. 882/2004 ter členov 2 in 3 Uredbe (ES) št. 178/2002 se za na namen te uredbe uporabljajo naslednje opredelitve:
In addition to the definitions laid down in Article 1 of Directive 2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and Articles 2 and 3 of Regulation (EC) No 178/2002, the following definitions shall apply for the purposes of this Regulation:
MEJNE VREDNOSTI OSTANKOV
MAXIMUM RESIDUE LIMITS
POGLAVJE 1 OCENA IN OBVLADOVANJE TVEGANJA
CHAPTER 1 RISK ASSESSMENT AND RISK MANAGEMENT
Farmakološko aktivne snovi, namenjene za uporabo v zdravilih za uporabo v veterinarski medicini
Pharmacologically active substances intended for use in veterinary medicinal products
Vloga za mnenje Agencije
Application for an opinion of the Agency
Zato imetnik dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, v katerem se takšna snov uporablja, vložnik zahtevka za izdajo takšnega dovoljenja za promet ali oseba, ki namerava takšno dovoljenje za promet uporabiti, predloži vlogo Agenciji.
To that end, the holder of a marketing authorisation for a veterinary medicinal product in which such a substance is used, the applicant for such a marketing authorisation or a person intending to apply for such a marketing authorisation, shall submit an application to the Agency.
Mnenje Agencije
Opinion of the Agency
Mnenje Agencije vsebuje znanstveno oceno tveganja in priporočila o obvladovanju tveganja.
The opinion of the Agency shall consist in a scientific risk assessment and risk management recommendations.
V teh priporočilih je treba preko pisem o sodelovanju upoštevati vsa ustrezna znanstvena dognanja Evropske agencije za varnost hrane.
Such recommendations shall take into account any relevant scientific findings of the European Food Safety Authority, by way of letters of cooperation.
Za zagotavljanje dostopnosti odobrenih zdravil za uporabo v veterinarski medicini v razmerah, ki vplivajo na vrste za proizvodnjo živil, Odbor pri izvajanju znanstvene ocene tveganja in oblikovanju priporočil o obvladovanju tveganj prouči uporabo mejnih vrednosti ostankov, določenih za farmakološko aktivne snovi v posameznem živilu, za drugo živilo iz enake vrste ali mejnih vrednosti snovi, določenih v eni ali več vrstah, za druge vrste.
With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing species, the Committee shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using maximum residue limits established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or in one or more species for other species.
Znanstvena ocena tveganja
Scientific risk assessment
Znanstvena ocena tveganja upošteva presnovo in izločanje farmakološko aktivnih snovi v ustreznih živalskih vrstah ter vrsto ostankov in njihovo količino, ki jo lahko ljudje zaužijejo v življenjskem obdobju brez povzročitve tveganja za zdravje in ki je izražena s sprejemljivim dnevnim vnosom.
The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species and the type of residues, and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk expressed in terms of acceptable daily intake (ADI).
Znanstvena ocena tveganja zadeva naslednje:
The scientific risk assessment shall concern the following:
vrsto in količino ostankov, za kateri velja, da ne pomenita nevarnosti za zdravje ljudi;
the type and amount of residue considered not to present a safety concern for human health;
farmakoloških ali mikrobioloških učinkov pri ljudeh;
pharmacological or microbiological effects in human beings;
ostanke, ki se pojavijo v živilih rastlinskega izvora ali prihajajo iz okolja.
residues that occur in food of plant origin or come from the environment.
Če presnove in izločanja snovi ni mogoče oceniti, uporaba snovi pa je namenjena spodbujanju zdravja in blaginje živali, lahko znanstvena ocena tveganja upošteva podatke o spremljanju ali izpostavljenosti.
If the metabolism and depletion of the substance cannot be assessed and the use of the substance is designed to promote animal health and welfare, the scientific risk assessment may take into account monitoring data or exposure data.
Priporočila o obvladovanju tveganja
Risk management recommendations
in živalske krme
and animal feed
, izvedljivost nadzora, pogoji uporabe in aplikacije snovi v zdravilih za uporabo v veterinarski medicini
production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products
, upoštevanje dobre veterinarske prakse
, compliance with good veterinary practice
ter verjetnost zlorabe ali nezakonite uporabe
and the likelihood of misuse or illegal use;
Nominalna karenca pri zdravilih za uporabo v veterinarski medicini, ki nimajo mejne vrednosti ostankov za kopitarje, niso vključena v Prilogo IV Uredbe (EGS) št. 2377/90 ali člen 13(2) te uredbe in katerih uporaba "ni v skladu s povzetkom značilnosti zdravil", kakor je opredeljeno v členu 1(16) Direktive 2001/82/ES, in se uporabljajo v skladu s "kaskadnimi določbami" iz členov 10 in 11 Direktive 2001/82/ES ter se ne dajejo v mišico ali podkožno, je šest mesecev.
Veterinary medicinal products which do not have a maximum residue limit for equidae, which are not included in Annex IV of Regulation (EEC) No 2377/90 or in Article 13(2) of this Regulation, and which are used "off-label", as defined in Article 1(16) of Directive 2001/82/EC, and under the provisions of Articles 10 and 11 in Directive 2001/82/EC and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months.
Uporaba farmacevtskih izdelkov s farmakološko aktivnimi sestavinami, ki niso na seznamu bistvenih snovi za zdravljenje za kopitarje iz člena 10(3) Direktive 2001/82/ES in se ne dajejo v mišico ali podkožno, ima nominalno karenco šest mesecev.
The use of pharmaceuticals containing pharmacologically active ingredients not on the list of substances essential for the treatment of equidae referred to in Article 10(3) of Directive 2001/82/EC and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months.
Vloge in postopki
Applications and procedures
Vloge iz člena 3 so v skladu z obliko in vsebino, ki ju je določila Komisija v členu 12(1), in jim je priložena pristojbina, ki jo je treba plačati Agenciji.
The application referred to in Article 3 shall comply with the format and content laid down by the Commission as provided for in Article 12(1) and shall be accompanied by the fee payable to the Agency.
kadar Agencija zahteva predložitev dodatnih informacij o zadevni snovi v določenem obdobju, preklic pa traja do predložitve zahtevanih dodatnih informacij.
This time limit shall be suspended when the Agency requests the submission of supplementary information on the given substance within a specific time period, and until such time as the supplementary information requested has been provided.
Agencija mnenje iz člena 4 posreduje vložniku zahtevka.
The Agency shall forward the opinion referred to in Article 4 to the applicant.
V 15 dneh po prejemu mnenja lahko predlagatelj pošlje Agenciji pisno obvestilo, da želi ponoven pregled mnenja.
Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to request a re-examination of the opinion.
V navedenem primeru vložnik v 60 dneh od prejema mnenja posreduje Agenciji natančne razloge za svojo zahtevo.
In that case the applicant shall forward the detailed grounds for his request to the Agency within 60 days of receipt of the opinion.
Odbor v 60 dneh od prejema razlogov za zahtevo prouči, ali je treba mnenje spremeniti.
Within 60 days of the receipt of the grounds for the request, the Committee shall consider whether its opinion should be revised.