natgillin/translations-raw huggingface dataset:
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 [4] provides that veterinary medicinal products may be authorised or used in food-producing animals only if pharmacologically active substances contained therein have been assessed as safe according to Regulation (EEC) No 2377/90.
Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [4] določa, da se zdravila za uporabo v veterinarski medicini lahko odobrijo ali uporabljajo pri živalih, namenjenih za proizvodnjo hrane samo, če so bile farmakološko aktivne snovi v teh zdravilih ocenjene za varne v skladu z Uredbo (EGS) št. 2377/90.
Moreover that Directive contains rules concerning the documentation of use, re-designation (off label use), prescription and distribution of veterinary medicinal products intended for use in food-producing animals.
Poleg tega vsebuje navedena direktiva pravila glede dokumentacije za uporabo, izjemno uporabo („uporabo, ki ni v skladu s povzetkom značilnosti zdravila“), predpisovanja in distribucije zdravil za uporabo v veterinarski medicini, ki so namenjena uporabi pri živalih, namenjenih za proizvodnjo hrane.
In the light of the European Parliament’s resolution of 3 May 2001 [5] on the availability of veterinary medicinal products, the Commission’s public consultation undertaken in 2004 and its 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.
Ob upoštevanju resolucije Evropskega parlamenta z dne 3. maja 2001 [5] o razpoložljivosti zdravil za uporabo v veterinarski medicini, javnega posvetovanja Komisije leta 2004 in njene ocene o pridobljenih izkušnjah se zdi potrebno spremeniti postopke za določitev najvišjih mejnih vrednosti ostankov ter hkrati ohraniti splošen sistem določanja teh mejnih vrednosti.
Maximum residue limits are the points of reference for the establishment, in accordance with Directive 2001/82/EC, of withdrawal periods in marketing authorisations for veterinary medicinal products to be used in food-producing animals as well as for the control of residues in food of animal origin in the Member States and at border inspection posts.
Najvišje mejne vrednosti ostankov se štejejo za referenčne vrednosti, ko je treba v skladu z Direktivo 2001/82/ES določiti obdobja karence pri izdaji dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki se uporabljajo pri živalih, namenjenih za proizvodnjo hrane, in preveriti ostanke v živilih živalskega izvora v državah članicah in na mejnih kontrolnih točkah.
Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock-farming of certain substances having a hormonal or thyrostatic action and of β-agonists [6] prohibits the use of certain substances for specific purposes in food-producing animals.
Direktiva Sveta 96/22/ES z dne 29. aprila 1996 o prepovedi uporabe v živinoreji določenih snovi, ki imajo hormonalno ali tirostatično delovanje, in ß-agonistov [6] prepoveduje uporabo nekaterih snovi za posebne namene pri živalih, namenjenih za proizvodnjo hrane.
This Regulation should apply without prejudice to any Community legislation prohibiting the use in food-producing animals of certain substances having a hormonal action.
To uredbo bi bilo treba uporabljati brez poseganja v zakonodajo Skupnosti o prepovedi uporabe nekaterih snovi s hormonalnim delovanjem pri živalih, namenjenih za proizvodnjo hrane.
Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food [7] lays down specific rules for substances not resulting from intentional administration.
Uredba Sveta (EGS) št. 315/93 z dne 8. februarja 1993 o določitvi postopkov Skupnosti za kontaminate v hrani [7] določa posebna pravila za snovi, ki niso posledica namenskega dajanja.
Those substances should not be subject to legislation on maximum residue limits.
Za navedene snovi se ne bi smela uporabljati zakonodaja o najvišjih mejnih vrednostih ostankov.
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] lays down the framework for food legislation at Community level and provides for definitions in that area.
Uredba (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] določa okvir za zakonodajo na področju hrane na ravni Skupnosti in določa opredelitve na navedenem področju.
It is appropriate that those definitions apply for the purposes of legislation on maximum residue limits.
Primerno je, da se te opredelitve uporabljajo za namene zakonodaje o najvišjih mejnih vrednostih ostankov.
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [9] lays down general rules for the control of food in the Community and provides for definitions in that area.
Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [9] določa splošna pravila za nadzor hrane v Skupnosti in zagotavlja opredelitve na navedenem področju.
It is appropriate that those rules and definitions apply for the purposes of legislation on maximum residue limits.
Primerno je, da se ta pravila in opredelitve uporabljajo za namene zakonodaje o najvišjih mejnih vrednostih ostankov.
Priority should be given to the detection of the illegal use of substances and part of the samples should be selected according to a risk-based approach.
Prednost bi bilo treba dati odkrivanju prepovedane in nedovoljene uporabe snovi, del vzorcev pa bi bilo treba izbrati na podlagi pristopa, ki temelji na oceni tveganja.
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 [10] entrusts the European Medicines Agency (the Agency) with the task of advising on the maximum residue limits for veterinary medicinal products which may be accepted in food of animal origin.
Uredba (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 [10] podeljuje Evropski agenciji za zdravila (v nadaljnjem besedilu „agencija“) nalogo svetovanja o najvišjih mejnih vrednostih ostankov zdravil za uporabo v veterinarski medicini, ki so v živilih živalskega izvora sprejemljive.
Maximum residue limits should be set for pharmacologically active substances used or intended to be used in veterinary medicinal products placed on the market in the Community.
Določiti bi bilo treba najvišje mejne vrednosti ostankov za farmakološko aktivne snovi, ki se uporabljajo ali so namenjene za uporabo v zdravilih za uporabo v veterinarski medicini, ki se dajejo v promet v Skupnosti.
It appears from the public consultation and from the fact that only a small number of veterinary medicinal products for food-producing animals have been authorised in recent years that Regulation (EEC) No 2377/90 has resulted in such medicinal products being less readily available.
Javno posvetovanje in dejstvo, da je bilo v zadnjih letih odobreno le majhno število zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane, kažeta, da je rezultat Uredbe (EGS) št. 2377/90, da je takšnih zdravil manj na razpolago.
In order to ensure animal health and welfare, it is necessary that veterinary medicinal products are available to treat specific disease conditions.
Za zagotovitev zdravja in dobrega počutja živali bi morala biti na razpolago zdravila za uporabo v veterinarski medicini za zdravljenje posebnih bolezenskih stanj.
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.
Poleg tega lahko nezadostna razpoložljivost ustreznih zdravil za uporabo v veterinarski medicini za posebno zdravljenje določene živalske vrste povzroči zlorabo ali nedovoljeno oziroma prepovedano uporabo snovi.
The system established by Regulation (EEC) No 2377/90 should therefore be modified with a view to increasing the availability of veterinary medicinal products for food-producing animals.
Sistem, vzpostavljen z Uredbo (EGS) št. 2377/90, bi bilo treba spremeniti zato, da se poveča razpoložljivost zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane.
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.
Za dosego tega cilja bi bilo treba predvideti, da agencija sistematično preuči uporabo najvišje mejne vrednosti ostankov, določene za eno živalsko vrsto ali živilo, pri drugi živalski vrsti ali drugem živilu.
In this respect, the adequacy of the safety factors already inherent in the system should be taken into account in order to ensure that food safety and animal welfare are not compromised.
Zato bi bilo treba upoštevati ustreznost varnostnih faktorjev, ki so že vključeni v sistem, da se zagotovi, da nista ogrožena varnost hrane in dobro počutje živali.
It is recognised that, in certain cases, scientific risk assessments alone cannot provide all the information on which risk management decisions should be based and that other factors relevant to the matter under consideration should legitimately be taken into account, including the technological aspects of food production and the feasibility of controls.
Znano je, da v nekaterih primerih sama znanstvena ocena tveganja ne more zagotoviti vseh informacij, na katerih naj bi temeljile odločitve o obvladovanju tveganja, in da bi bilo treba upoštevati tudi druge ustrezne dejavnike, vključno s tehnološkimi vidiki proizvodnje hrane in izvedljivostjo nadzora.
The Agency should therefore provide an opinion consisting of a scientific risk assessment and risk management recommendations on residues of pharmacologically active substances.
Agencija bi morala zato dati mnenje o znanstveni oceni tveganja in priporočila za obvladovanje tveganj glede ostankov farmakološko aktivnih snovi.
Detailed rules on the format and content of applications for the establishment of maximum residue limits and on methodological principles of risk assessment and of risk management recommendations are necessary for the smooth functioning of the whole framework of maximum residue limits.
Za nemoteno delovanje celotnega okvira najvišjih mejnih vrednosti ostankov so nujna podrobna pravila o obliki in vsebini vlog za določitev najvišjih mejnih vrednosti ostankov ter o metodoloških načelih ocene tveganja in priporočil za obvladovanje tveganja.
Besides veterinary medicinal products, other products which are not subject to specific legislation on residues, such as biocidal products, are used in animal husbandry.
Poleg zdravil za uporabo v veterinarski medicini se v živinoreji uporabljajo tudi drugi proizvodi, kot so na primer biocidni pripravki, ki niso urejeni s posebno zakonodajo o ostankih.
These biocidal products are defined in 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 [11].
Ti biocidni pripravki so opredeljeni v Direktivi 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promett [11].
Furthermore, veterinary medicinal products not having a marketing authorisation in the Community may be authorised in countries outside the Community.
Poleg tega se zdravila za uporabo v veterinarski medicini, ki v Skupnosti niso dovoljena, lahko odobrijo v državah zunaj Skupnost.
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.
To je mogoče, ker v drugih regijah bolj prevladujejo druge bolezni ali ciljne vrste ali ker so se podjetja odločila, da proizvoda v Skupnosti ne bodo dala v promet.
The fact that a product is not authorised in the Community does not necessarily indicate that its use is unsafe.
Dejstvo, da proizvod v Skupnosti ni odobren, ne pomeni nujno, da je njegova uporaba nevarna.
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.
V zvezi s farmakološko aktivnimi snovmi takšnih proizvodov bi moralo biti Komisiji omogočeno določanje najvišjih mejnih vrednosti ostankov za živila, in sicer na podlagi mnenja agencije v skladu z načeli za farmakološko aktivne snovi, namenjene uporabi v zdravilih za uporabo v veterinarski medicini.
It is also necessary to amend Regulation (EC) No 726/2004 to include, within the tasks of the Agency, advising on the maximum levels of residues of active substances in biocidal products.
Treba bi bilo tudi spremeniti Uredbo (ES) št. 726/2004, in sicer zato, da se med naloge agencije vključi svetovanje glede najvišjih mejnih vrednosti ostankov aktivnih snovi v biocidnih pripravkih.
Under the system established by Directive 98/8/EC, operators having placed or seeking to place biocidal products on the market are obliged to pay charges for the evaluations carried out pursuant to different procedures associated with that Directive.
V skladu s sistemom, vzpostavljenim z Direktivo 98/8/ES, morajo osebe, ki so dale ali želijo dati v promet biocidne pripravke, plačati stroške ocen, opravljenih v skladu z različnimi postopki, povezanimi s to direktivo.
This Regulation provides that the Agency is to carry out evaluations related to the establishment of the maximum residue limit for pharmacologically active substances intended to be used in biocidal products.
Ta uredba določa, da agencija izvaja ocene v zvezi z določanjem najvišjih mejnih vrednosti ostankov farmakološko aktivnih snovi, namenjenih uporabi v biocidnih pripravkih.
As a consequence, this Regulation should clarify how those evaluations are financed, in order to take due account of fees already collected for evaluations carried out, or to be carried out, under that Directive.
Posledično bi morala ta uredba razjasniti podrobnosti glede financiranja teh ocen, da bi se ustrezno upoštevale pristojbine, že pobrane za ocene, ki so bile opravljene ali bodo opravljene v skladu z navedeno direktivo.
The Community contributes, in the context of the Codex Alimentarius, to the development of international standards on maximum residue limits, while ensuring that the high level of protection of human health maintained in the Community is not reduced.
Skupnost v okviru Codex Alimentarius prispeva k pripravi mednarodnih standardov o najvišjih mejnih vrednostih ostankov in hkrati preprečuje, da bi se visoka raven varovanja zdravja ljudi, ki se vzdržuje v Skupnosti, ne bi zmanjšala.
The Community should therefore take over without a further risk assessment those Codex Alimentarius maximum residue limits it has supported in the relevant Codex Alimentarius Commission meetings.
Skupnost bi morala zato brez dodatne ocene tveganja prevzeti v Codexu Alimentariusu navedene mejne vrednosti ostankov, za katere se je zavzemala na ustreznem sestanku Komisije Codex Alimentarius.
Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced.
Tako se bo še povečala usklajenost mednarodnih standardov in zakonodaje Skupnosti glede mejnih vrednosti ostankov v živilih.
Foodstuffs are subject to controls on residues of pharmacologically active substances in accordance with Regulation (EC) No 882/2004.
Pri živilih se izvaja nadzor ostankov farmakološko aktivnih snovi v skladu z Uredbo (ES) št. 882/2004.
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 the occurrence of a natural metabolite in the animal.
Čeprav mejne vrednosti ostankov za takšne snovi v tej uredbi niso določene, se lahko ostanki takšnih snovi pojavijo zaradi onesnaženosti okolja ali pojava naravnega metabolita v živali.
Laboratory methods are capable of finding such residues at ever lower levels.
Z laboratorijskimi metodami je mogoče dokazati vedno nižje vrednosti takšnih ostankov.
Such residues have caused different control practices in Member States.
Takšni ostanki so privedli do različnih nadzornih praks v državah članicah.
Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries [12] requires that each consignment imported from a third country is subject to veterinary controls, and Commission Decision 2005/34/EC [13] lays down harmonised standards for the testing for certain residues in products of animal origin imported from third countries.
Direktiva Sveta 97/78/ES dne 18. decembra 1997 o določitvi načel, ki urejajo organizacijo veterinarskih pregledov proizvodov, ki vstopajo v Skupnost iz tretjih držav [12] zahteva, da je vsaka pošiljka, ki se uvozi iz tretjih držav, predmet veterinarskega pregleda, Odločba Komisije 2005/34/ES [13] pa določa usklajene standarde za preizkušanje določenih ostankov v proizvodih živalskega izvora, uvoženih iz tretjih držav.
It is appropriate to extend the provisions of Decision 2005/34/EC to all products of animal origin placed on the Community market.
Primerno je, da se določbe Odločbe 2005/34/ES razširi na vse izdelke živalskega izvora, ki se dajo na trg v Skupnosti.
A number of pharmacologically active substances are prohibited or currently not authorised under Regulation (EC) No 2377/90, Directive 96/22/EC or Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [14].
V skladu z Uredbo (ES) št. 2377/90, Direktivo 96/22/ES ali Uredbo (ES) št. 1831/2003 Evropskega parlamenta in Sveta dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [14] je veliko farmakološko aktivnih snovi prepovedanih ali pa trenutno niso odobrene.
The residues of pharmacologically active substances in products of animal origin arising, in particular, from illegal use or from environmental contamination should be carefully controlled and monitored in accordance with Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products [15], regardless of the origin of the product.
Ostanke farmakološko aktivnih snovi v proizvodih živalskega izvora, ki izvirajo predvsem iz prepovedane ali nedovoljene uporabe ali iz onesnaženosti okolja, bi bilo treba ne glede na poreklo izdelka pazljivo nadzirati in spremljati v skladu z Direktivo Sveta 96/23/ES dne 29. aprila 1996 o ukrepih za spremljanje nekaterih snovi in njihovih ostankov v živih živalih in v živalskih proizvodih [15].
It is appropriate for the Community to provide for procedures to set reference points for action at concentrations of the residues for which laboratory analysis is technically feasible in order to facilitate intra-Community trade and imports, without undermining a high level of protection of human health in the Community.
Zaradi omogočanja lažje trgovine znotraj Skupnosti in uvoza v Skupnost je primerno, da Skupnost predvidi postopke za določitev referenčnih vrednosti za ukrepe pri koncentracijah ostankov, pri katerih je laboratorijska analiza tehnično izvedljiva, pri čemer se ne ogrozi visoke ravni varovanja zdravja ljudi v Skupnosti.
However, the setting of reference points for action should in no way serve as a pretext for condoning the illegal use of prohibited or non-authorised substances to treat food-producing animals.
Vendar določitev referenčnih vrednosti za ukrepe nikakor ne bi smela služiti kot izgovor za toleriranje prepovedane ali nedovoljene uporabe prepovedanih ali nedovoljenih snovi pri zdravljenju živali, namenjenih za proizvodnjo hrane.
Therefore, any residues of those substances in food of animal origin should be considered undesirable.
Zato bi bilo potrebno vse ostanke teh snovi v živilih živalskega izvora obravnavati kot nezaželene.
It is also appropriate for the Community to establish a harmonised approach for situations where Member States find evidence of a recurrent problem, since such a finding could suggest a pattern of misuse of a particular substance or a disregard for guarantees provided by third countries concerning the production of food intended for import into the Community.
Prav tako je primerno, da Skupnost vzpostavi usklajen pristop za primer, če države članice najdejo dokaze o ponavljajočem se problemu, saj takšna ugotovitev lahko nakazuje na vzorec napačne uporabe določene snovi ali neupoštevanje jamstev, zagotovljenih v tretjih državah v zvezi s proizvodnjo hrane, namenjene za uvoz v Skupnost.
Member States should notify the Commission of recurring problems, and appropriate follow-up measures should be taken.
Države članice bi morale Komisijo obvestiti o ponavljajočih se problemih, sprejeti pa bi bilo treba tudi ustrezne nadaljnje ukrepe.
The current legislation on maximum residue limits should be simplified by placing together in one single Commission regulation all decisions classifying pharmacologically active substances as regards residues.
Veljavno zakonodajo o najvišjih mejnih vrednostih ostankov bi bilo treba poenostaviti tako, da bi bile vse odločitve o razvrstitvi farmakološko aktivnih snovi glede na ostanke združene v eni uredbi Komisije.
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [16].
Ukrepi, potrebni za izvajanje te uredbe, bi se morali sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [16].
In particular, the Commission should be empowered to adopt methodological principles for the risk assessment and risk management recommendations regarding the establishment of maximum residue limits, rules on the conditions for extrapolation, measures setting reference points for action, including measures reviewing those reference points, as well as methodological principles and scientific methods for the establishment of reference points for action.
Zlasti bi bilo treba Komisiji podeliti pooblastila za sprejetje metodoloških načel ocene tveganja in priporočil za obvladovanje tveganja v zvezi z določitvijo najvišjih mejnih vrednosti ostankov, pravil o pogojih za ekstrapolacijo, ukrepov, ki določajo referenčne vrednosti za ukrepe, vključno z ukrepi za pregled teh referenčnih vrednosti, pa tudi metodoloških načel in znanstvenih metod za določitev referenčnih vrednosti za ukrepe.