natgillin/translations-raw huggingface dataset:
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
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
MNENJE ODBORA ZA PRAVNE ZADEVE O PREDLAGANI PRAVNI PODLAGI............32
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE PROPOSED LEGAL BASIS 33
MNENJE Odbora za kmetijstvo in razvoj podeželja .......................................38
OPINION of the Committee on Agriculture and Rural Development ...39
– 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 o 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 ),
Uvodna izjava 1
Citation 1
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti ter zlasti členov 37 in 152(4)(b) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Article 37 and Article 152(4)(b) thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti ter zlasti člena 152(4)(b) Pogodbe,
Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,
Dvojna pravna podlaga je upravičena le, če eden od obeh ciljev pravnega akta ni sekundaren drugemu.
There is only a valid justification for a dual legal basis if one of the two objectives of a legal act is not secondary to the other.
V tem primeru je javno zdravje brez dvoma glavni cilj (gl. uvodno izjavo 26), zato je člen 37 kot pravna podlaga nepotreben in celo odvečen.
In this case public health is clearly the dominating objective (see recital 26) which makes Article 37 non-essential and even redundant as a legal basis.
(1a) Kljub temu, da je bil s členoma 10 in 11 Direktive 2001/82/ES 1 uveden t. i. kaskadni postopek, s katerim bi omogočilo zdravljenje živali v primerih, ko ni dovoljenega zdravila za uporabo v veterinarski medicini, se EU še vedno sooča z mnogimi terapevtskimi potrebami po zdravilih za uporabo v veterinarski medicini.
(1a) Despite the existence of the so-called ‘cascade’ procedure introduced by Articles 10 and 11 of Directive 2001/82/EC 1 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 EU.
S tem izzivom se je treba nujno soočiti s pomočjo temeljitega pregleda zakonodaje o odobritvi zdravil za uporabo v veterinarski medicini.
There is an urgent need to address this challenge through a fundamental review of the legislation governing the authorisation of veterinary medicines.
Takšen pregled bi moral inovacije in konkurenčnost industrije, povezane z zdravjem živali, ohraniti v ravnotežju z regulativnimi zahtevami.
Such a review should balance innovation and the competitiveness of the animal health industry with the regulatory requirements.
Posebno pozornost je treba nameniti odobritvi generičnih zdravil za uporabo v veterinarski medicini, pri katerih oprostitve ekskluzivnosti podatkov od standardov glede varnosti in učinkovitosti ne veljajo za zahteve za študije o okoljskih učinkih.
Special attention needs to be paid to the authorisation of generic veterinary medicines where data exclusivity waivers from the safety and efficacy standards do not apply to the requirements for the environmental impact studies.
Prav tako je treba posebno pozornost nameniti skrbi za posebnosti sektorja zdravja živali v EU, 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, being 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.
1 Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str.
1 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 (OJ L 311, 28.11.2001, p.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2004/28/ES (UL L 136, 30.4.2004, str.
Directive as last amended by Directive 2004/28/EC (OJ L 136 , 30.4.2004, p.
(1a) 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.
(1b) 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.
Upoštevati bi bilo treba tudi druge morebitne znanstvene ocene varnosti zadevnih snovi, ki so jih opravile mednarodne organizacije ali znanstveni odbori s sedežem v Skupnosti.
Other scientific assessments of the safety of substances concerned which may have been undertaken by international organisations or scientific committees established within the Community should also be taken into account.
(5) Z vidika 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.
(5) In the light of the 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.
(5) Z vidika resolucije Evropskega parlamenta z dne 3. maja 2001 o dostopnosti zdravil za uporabo v veterinarski medicini 1 , 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.
(5) In the light of the European Parliament's resolution of 3 May 2001 on the availability of veterinary medicinal products 1 , the 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.
1 UL C 27 E, 31.1.2002, str.
1 OJ C 27 E, 31.1.2002, p.
(10) 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 10 določa splošna pravila za nadzor hrane v Evropski skupnosti in zagotavlja opredelitve na navedenem področju.
(10) 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 10 lays down general rules for the control of food in the European Community and provides for definitions in that area.
Primerno je, da se navedene opredelitve uporabljajo za namene zakonodaje o mejnih vrednostih ostankov.
It is appropriate that those definitions should apply for the purposes of the legislation on maximum residue limits.
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 .
(16) Za varovanje zdravja ljudi bi bilo treba določiti mejne vrednosti ostankov v skladu s splošno priznanimi načeli presoje varnosti, ob upoštevanju toksikoloških tveganj, okoljske onesnaženosti pa tudi nepredvidenih mikrobioloških in farmakoloških učinkov ostankov.
(16) In order to protect human 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.
(20) Skupnost v okviru Codexa Alimentariusa prispeva k razvoju mednarodnih standardov o mejnih vrednostih ostankov ter hkrati preprečuje znižanje visoke ravni varovanja zdravja ljudi, sprejete v Skupnosti.
(20) 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 human health protection adopted in the Community is not reduced.
Skupnost bi morala zato brez nadaljnje ocene tveganja prevzeti navedene mejne vrednosti ostankov iz Codexa, ki jih je podprla na ustreznem sestanku Komisije Codex Alimentarius.
The Community should therefore take over without a further risk assessment those Codex maximum residue limits it has supported in the relevant Codex Alimentarius Commission meeting.
Tako se bo še povečala usklajenost mednarodnih standardov in zakonodaje Skupnosti glede vrednosti ostankov v živilih.
Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced.
Skupnost bi morala zato prevzeti navedene mejne vrednosti ostankov iz Codexa, ki jih je podprla na ustreznem sestanku Komisije Codex Alimentarius , s pridržkom pregleda snovi, ki v EU niso dovoljene, ter določenih snovi, katerih sinergični in kumulativni učinki so lahko zdravju škodljivi.
The Community should therefore take over those Codex maximum residue limits it has supported in the relevant Codex Alimentarius Commission meeting, subject to a review of substances not authorised in the EU and of specific synergetic and cumulative effects of specific substances that may harm human health .
Tako se bo še povečala usklajenost mednarodnih standardov in zakonodaje Skupnosti glede vrednosti ostankov v živilih ne da bi se ogrozila stopnja varnosti, potrebna za pridobitev dovoljenja v Skupnosti .
Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced , without jeopardising the level of protection required for authorisation in the Community .
Komisija mora še preden bo dosežen dogovor v sodelovanje uradno vključiti Evropski parlament.
The Commission must involve the European Parliament formally before agreement is reached.
(22) Zato je primerno, da Skupnost zagotovi postopke za določitev referenčnih točk za nadzor koncentracij ostankov, za katere je v skladu z znanstvenim nasvetom izpostavljenost potrošnikov zanemarljiva in laboratorijska analiza tehnično izvedljiva, da se spodbudita trgovina in uvoz znotraj Skupnosti.
(22) It is therefore appropriate for the Community to provide for procedures to set reference points for control action at concentrations of the residues for which scientific advice indicates that consumer exposure is negligible and laboratory analysis is technically feasible in order to facilitate intra-Community trade and imports.
(22) Zato je primerno, da Skupnost zagotovi postopke za določitev referenčnih točk za nadzor koncentracij ostankov, za katere je laboratorijska analiza tehnično izvedljiva, da se spodbudita trgovina in uvoz znotraj Skupnosti brez ogrožanja visoke ravni varovanja zdravja ljudi v Skupnosti.
(22) It is therefore appropriate for the Community to provide for procedures to set reference points for control 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 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.
Vse ostanke teh snovi v živilih je treba obravnavati kot nezaželene.
Therefore, any residues of those substances in food must be considered undesirable .
Člen 1 – odstavek 1 – uvodni del
Article 1 – paragraph 1 – introductory part
Ta uredba določa pravila in postopke za določitev:
T his Regulation lays down rules and procedures in order to establish the following:
Za zagotavljanje varnosti hrane ta uredba določa pravila in postopke za določitev:
For the purpose of ensuring food safety, t his Regulation lays down rules and procedures in order to establish the following:
Člen 1 – odstavek 1 – točka (b)
Article 1 – paragraph 1 – point (b)
(b) ravni tolerance ostanka farmakološko aktivne snovi, pod katero se izpostavljenost ljudi navedenemu ostanku prek živila, ki vsebuje snov, obravnava kot zanemarljiva („ referenčna točka za ukrepe“).
(b) the tolerance level of a residue of a pharmacologically active substance below which human exposure to that residue through food containing the substance is considered negligible ("reference point for action").
(b) ravni ostanka farmakološko aktivne snovi, določene zaradi nadzora v primeru nekaterih snovi, za katere mejna vrednost ostanka ni določena v skladu s to uredbo („ referenčne točke za ukrepe“).
(b) the level of a residue of a pharmacologically active substance , 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 ("reference points for action").
Člen 4 – odstavek 2
Article 4 - paragraph 2
Namen znanstvene ocene tveganja in priporočil o obvladovanju tveganja je zagotoviti visoko raven varovanja zdravja ljudi ter hkrati zagotoviti, da pomanjkanje dostopnosti ustreznih zdravil za uporabo v veterinarski medecini ne bo negativno vplivalo na zdravje ljudi in živali ter blaginjo živali.
The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.
Namen znanstvene ocene tveganja in priporočil o obvladovanju tveganja je zagotoviti visoko raven varovanja zdravja ljudi ter hkrati zagotoviti, da pomanjkanje dostopnosti ustreznih zdravil za uporabo v veterinarski medicini ne bo negativno vplivalo na zdravje ljudi in živali ter blaginjo živali.
The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.
V teh priporočilih je treba preko pisem o sodelovanju upoštevati vsa ustrezna znanstvena dognanja Evropske agencije za varnost hrane.
Such recommendations should 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.
Odbor v skladu s ciljem zagotavljanja visoke ravni varovanja zdravja in v skladu z načeli, določenimi v členu 6, za zagotavljanje dostopnosti odobrenih zdravil za uporabo v veterinarski medicini v razmerah, ki vplivajo na vrste za proizvodnjo živil, 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.
In line with the objective of ensuring a high level of health protection and with the principles laid down in Article 6, the Committee shall, with a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food—producing species, 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.
V primeru ekstrapolacije med različnimi živalskimi vrstami je pri določanju mejnih vrednosti ostankov treba uporabiti varnostni faktor.
In the event of extrapolation between different animal species, a safety factor should be applied when setting maximum residue limits.
Poročevalec podpira cilj predloga Komisije za izboljšanje preskusnih postopkov z okrepljeno uporabo ekstrapolacije (prenosa rezultatov na druge vrste živil oziroma živalske vrste) med presojo tveganja.
The rapporteur supports the objective set out in the Commission proposal of improving test procedures by making greater use of extrapolation (i.e. applying results to other foodstuffs or animal species) during risk assessment.
Posebej v primeru manjših skupin živali (koze, ovce itd.) bo ta cilj prispeval k večji dostopnosti aktivnih snovi.
This objective will contribute to increasing the availability of active substances, particularly for smaller groups of animals (goats, sheep etc.).
Tukaj predlagane spremembe naj bi zagotovile ustrezno znižanje dovoljenih ostankov snovi tudi pri uporabi ekstrapolacije.
The changes proposed here simply serve to ensure that, even when extrapolation is applied, there must be an appropriate reduction in authorised residue levels.
Člen 6 – odstavek 1
Article 6 — paragraph 1
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).
Uporabijo se lahko alternativni pristopi k sprejemljivemu dnevnemu vnosu, če jih je Komisija določila, kot predvideva člen 12(1).
Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1).
Znanstvena ocena tveganja upošteva presnovo in izločanje farmakološko aktivnih snovi pri različnih 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 zaužitjem, s posebnim poudarkom na sinergičnih in kumulativnih učinkih različnih farmakološko aktivnih snovi ter posledicah za občutljive skupine prebivalstva .
The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in different 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 ingestion (ADI) , paying particular attention to the synergetic and cumulative effects of different pharmacologically active substances and to effects on vulnerable categories of people .
Pri oceni tveganja je treba upoštevati načela presoje varnosti živil iz Uredbe (ES) št. 178/2002.
The risk assessment should comply with the principles for assessing the safety of foodstuffs laid down in Regulation (EC) No 178/2002.
Da se ohrani skladnost določitve mejnih vrednosti v skladu z živilsko zakonodajo, se je treba sklicevati na varnostna merila iz uredbe (ES) št. 178/2002, ki so merodajna za celotno živilsko zakonodajo.
In order to ensure that food law limit values are set consistently, mention should be made of the safety criteria laid down in Regulation (EC) No 178/2002, which serve as point of reference for food safety law as a whole.
Omenjena uredba upošteva med drugim ranljivost določenih skupin prebivalstva in sinergične ter kumulativne učinke.
Among other things, that Regulation provides for account to be taken of the particular vulnerability of certain categories of people, and of synergetic and cumulative effects.
Člen 6 – odstavek 2 – točka (b)
Article 6 – paragraph 2 – point (b)
(b) tveganje nepredvidenih farmakoloških ali mikrobioloških učinkov pri ljudeh;
(b) the risk of unintended pharmacological or microbiological effects in human beings;
(b) tveganje toksikoloških, farmakoloških ali mikrobioloških učinkov pri ljudeh;
(b) the risk of toxicological, pharmacological or microbiological effects in human beings;
Vključiti je treba tudi tveganje toksikoloških učinkov.
Toxicological risks should also be included.
Člen 7 – točka (b)
Article 7 — point (b)
(b) Drugih upravičenih dejavnikov, kot so tehnološki vidiki proizvodnje živil, izvedljivost nadzora, pogoji uporabe in aplikacije snovi v zdravilih za uporabo v veterinarski medicini ter verjetnost zlorabe ali nezakonite uporabe.
(b) other legitimate factors such as the technological aspects of food production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products and the likelihood of misuse or illegal use;
Člen 7 – točka (c)
Article 7 - point (c)
(c) Ali je treba določiti najvišjo ali začasno mejno vrednost ostanka za farmakološko aktivno snov v zdravilih za uporabo v veterinarski medicini, katere ostanki so bili ugotovljeni v posameznem živilu živalskega izvora, raven navedene najvišje dovoljene vrednosti ostankov in po potrebi kakršne koli pogoje ali omejitve za uporabo zadevne snovi.
(c) whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products , residues of which have been found in a particular foodstuff of animal origin, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;