natgillin/translations-raw huggingface dataset:
tj., da se pod določenimi pogoji mejna vrednost ostankov, določena za neko snov za eno ali več vrst, lahko uporablja za dodatne vrste, pri čemer znanstvenih raziskav ni treba potrditi s ponovnimi poskusi.
i.e. whereby under certain conditions the MRL fixed for a substance for one or more species can be applied to additional species without the need to replicate the fundamental scientific research.
Npr. živilo ð živilo: mišica ovce ð ledvica ovce in vrsta vrsta: ovce koze. kot obvezni del splošne znanstvene ocene in vzpostaviti pravno podlago za Komisijo za določitev načel za uporabo ekstrapolacije.
For example, foodstuff ð foodstuff: sheep muscle to sheep kidney and species ð species: sheep to goats. a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation.
To bo spodbudilo razvoj zdravil za manjše živali za proizvodnjo živil in tako zmanjšalo tveganje, ki ga za javno zdravje predstavlja uporaba zdravil, ki ni v skladu s povzetkom značilnosti zdravil.
This will encourage the development of drugs to cover minor food-producing animals and thereby diminish the risk to public health from "off-label" use of drugs.
Prav tako bo zmanjšalo stroške za razvoj novih zdravil ob ohranitvi visokih varnostnih mejnih vrednosti za javno zdravje;
It will also reduce the development costs of new drugs without changing the existing high safety margins for public health.
· uvesti obveznost prilagoditve zakonodaje Skupnosti za vključitev mejnih vrednosti ostankov, ki jih je določila komisija Codex Alimentarius
· Introduce an obligation to adapt Community legislation to include MRLs set at Codex Alimentarius
Komisija Codex Alimentarius Organizacije Združenih narodov za prehrano in kmetijstvo (FAO) in Svetovne zdravstvene organizacije (WHO) pripravlja prehranske standarde, smernice in s tem povezana besedila, kot je kodeks ravnanja v okviru skupnega programa organizacij FAO in WHO za prehranske standarde. s podporo EU, in tako zmanjšati dodatne in nepotrebne ocene,
The Codex Alimentarius Commission of the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO), develops food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. with the support of the EU, thus reducing additional and unnecessary assessments.
· vzpostaviti poseben pravni okvir za določitev mejnih vrednosti ostankov za farmakološko aktivne snovi, ki niso namenjene temu, da bodo odobrene kot zdravila za uporabo v veterinarski medicini, zlasti za namene nadzora in uvožena živila.
· Create a specific legal framework to set MRLs for pharmacologically active substances not intended to be authorised as veterinary medicines, in particular for control purposes and for imported food.
Predlog za dosego tega zagotavlja, da zahtevane spodnje meje zaznavanja (MRPL)
To achieve this, the proposal ensures Minimum Required Performance limits (MRPLs)
Zahtevane spodnje meje zaznavanja (MRPL) so bile prvič uvedene z Odločbo Komisije 2005/34/ES o določitvi usklajenih standardov za preizkušanje določenih ostankov v proizvodih živalskega izvora, uvoženih iz tretjih držav.
MRPLs were first introduced in Commission Decision 2005/34/EC laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries.
(kontrolni mehanizmi, ki temeljijo na nasvetih strokovnjakov in se uporabljajo kot referenčne točke za ukrepanje pri pregledih ob prestopu meje) temeljijo na trdnejših pravnih temeljih, kar izboljšuje varstvo potrošnikov in delovanje enotnega trga.
(control tools based on expert advice that are used as reference points for action at border inspection) are based on a sounder legal footing thus improving consumer protection and the functioning of the Single Market.
· preurediti zaporedje členov za vzpostavitev logične strukture, zlasti z razlikovanjem med določbami o oceni tveganja in upravljanju tveganja, da bi upoštevali cilj o „boljši ureditvi“;
· Rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment from risk management provisions, to comply with the objective of "Better Regulation."
· v predlagano uredbo vključiti pravila (mejne vrednosti ostankov, pogoji za uporabo, prepovedi) glede posameznih snovi, ki so sedaj v štirih prilogah trenutno veljavne uredbe, kar zopet pomeni boljšo ureditev in poenostavitev.
· Integrate into this proposed regulation the rules (MRLs, conditions of use, prohibitions) relating to individual substances, which are currently in 4 annexes of the current Regulation - again part of Better Regulation and simplification.
Kljub zamujeni priložnosti za utrditev ustrezne obstoječe zakonodaje poročevalec zelo pozdravlja predlagano rešitev za zagotovitev boljše zaščite zdravja ljudi in boljše dostopnosti zdravil za uporabo v veterinarski medicini, saj meni, da smo na takšno izboljšavo v sedanjem sistemu za določanje mejnih vrednosti ostankov že dolgo čakali.
Despite the missed opportunity for greater consolidation of the relevant existing legislation, I very much welcome the proposed solution to ensure greater protection of human health and greater availability of veterinary medicines, seeing it as a long-overdue improvement in the current system for the setting of MRLs.
Predlagani predlogi sprememb so v glavnem namenjeni pojasnjevanju in nimajo namena bistveno spreminjati predloga Komisije.
The amendments I have proposed are mainly for clarification and do not intend to substantially modify the Commission proposal.
Zadeva: Mnenje o pravni podlagi 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) )
Subject: Opinion on the legal basis of 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) )
V pismu z dne 26. marca 2008 ste v skladu s členom 35(2) poslovnika Odbor za pravne zadeve zaprosili za mnenje o točnosti in primernosti pravne podlage omenjenega predloga Komisije.
By letter of 26 March 2008 you asked the Committee on Legal Affairs pursuant to Rule 35(2), to consider whether the legal basis of the above Commission proposal was valid and appropriate.
Odbor je omenjeno vprašanje obravnaval na seji dne 8. aprila 2008.
The committee considered the above question at its meeting of 8 April 2008.
Predsednik Odbora za okolje, javno zdravje in varnost hrane Miroslav
The Chairman of the Committee on the Environment, Public Health and Food Safety, Miroslav
Ouzký je 26. marca 2008 na predsednika Odbora za pravne zadeve naslovil pismo z naslednjo vsebino:
Ouzký , has written a letter to the Chairman of the Legal Affairs Committee dated 26 March 2008 in the following terms:
"Odbor za okolje, javno zdravje in varnost hrane obravnava predlog uredbe o določitvi vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora ( KOM(2007)0194 ).
"The Committee on the Environment, Public Health and Food Safety is currently considering a proposal for a Regulation on establishment of residue limits of pharmacologically active substances in foodstuffs ( COM(2007)0194 ).
Predlog ima dvojno pravno podlago, in sicer člen 37 in člen 152(4) Pogodbe o ES.
The proposal has a dual legal basis, Article 37 and Article 152(4) of the EC Treaty.
Glede na navedeno prosim, naj Vaš odbor v skladu s členom 35(2) poslovnika pripravi mnenje o primernosti pravne podlage za ta predlog.
In view of the above, I would like to request your Committee to provide an opinion on the appropriateness of the legal basis for this proposal, pursuant to Rule 35(2) of the Rules of Procedure.
Hvaležen bi Vam bil, če bi mnenje lahko prejeli do 2. maja 2008, ker je po sedanjem razporedu predvideno, da bo glasovanje o osnutku poročila v Odboru ENVI 16. maja 2008."
I would greatly appreciate it if this opinion could be made available by 2 May 2008, in view of the vote on the draft report in the Environment Committee, currently scheduled for 6 May 2008."
Komisija kot pravno podlago dejansko predlaga člen 37 in člen 152(4)(b) Pogodbe, Avril Doyle pa predlaga samo njen člen 152(4)(b).
In point of fact, the Commission proposes that the legal basis should be Article 37 and Article 152(4)(b) of the Treaty, whereas Mrs Doyle is proposing that it should be Article 152(4)(b) alone.
Treba je navesti, da v obrazložitvi svojega predloga spremembe poročevalka pravi, da je v tem primeru "javno zdravje brez dvoma glavni cilj (gl. uvodno izjavo 26), zato je člen 37 kot pravna podlaga nepotreben in celo odvečen".
It is noted that in the justification to her amendment, the rapporteur states that "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".
Obravnavani pravni podlagi
The legal bases under consideration :
Države članice v povezavi s Komisijo medsebojno usklajujejo svoje politike in programe na področjih iz odstavka 1.
Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1.
Iz ustaljene prakse Sodišča je razvidno, da izbira pravne podlage ne sme biti subjektivna, pač pa "mora temeljiti na objektivnih dejavnikih, ki jih je mogoče sodno preskusiti"
According to the Court of Justice the choice of legal basis is not a subjective one, but "must be based on objective factors which are amenable to judicial review"
Predlog za uredbo Komisije temelji na členu 37 in na členu 152(4)(b) Pogodbe o ES, pri čemer se slednji nanaša na člen 37.
The Commission's proposal for a Regulation is based on both Article 37 of the EC Treaty and on Article 152(4)(b), which refers to Article 37.
Postavlja se vprašanje, ali je člen 152(4)(b) sam zadostna pravna podlaga.
The question which arises is whether Article 152(4)(b) would constitute a sufficient legal basis on its own.
Analiza predloga
Analysis of the proposal
V skladu z uvodno izjavo 26 sta cilja ukrepa, ki ga je treba sprejeti "varovanje zdravja ljudi in živali ter zagotavljanje dostopnosti ustreznih zdravil za uporabo v veterinarski medicini".
According to recital 26, "the objectives of the action to be taken" are "to protect human health as well as animal health, and to ensure the availability of appropriate veterinary medicinal products".
Vendar je bolj informativen člen 1 Vsebina in področje uporabe, ki določa:
What is more instructive, however, is Article 1, "Subject matter and scope", which provides as follows:
Ta uredba določa pravila in postopke za določitev:
This Regulation lays down rules and procedures in order to establish the following:
(a) najvišje koncentracije ostanka farmakološko aktivne snovi, ki se lahko dovoli v živilih živalskega izvora („mejna vrednost ostanka“);
(a) the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin ("maximum residue limit");
(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").
Ta uredba se ne uporablja za:
This Regulation shall not apply to the following:
(a) učinkovine biološkega izvora, namenjene ustvarjanju aktivne ali pasivne imunosti ali ugotavljanju stanja imunosti, ki se uporabljajo v imunoloških zdravilih za uporabo v veterinarski medicini;
(a) 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;
(b) snovi, ki spadajo na področje uporabe Uredbe (EGS) št. 315/93;
(b) substances falling within the scope of Regulation (ECC) No 315/93;
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."
Pregled ostalega dela predloga kaže na pomen člena 152(4)(b) Pogodbe o ES, saj je cilj ukrepa očitno varovanje zdravja ljudi z določitvijo mejnih vrednosti ostankov za farmakološko aktivne snovi glede različnih živil živalskega izvora (gl. uvodno izjavo 2).
Examination of the remainder of the proposal shows the relevance of Article 152(4)(b) of the EC Treaty, since the measure is clearly designed to protect human health by setting maximum residue limits for pharmacologically active substances in respect of various foodstuffs of animal origin (see recital 2).
Postopki, ki so opredeljeni, so po svoji naravi veterinarski, vendar imajo vseeno jasen cilj varovati zdravje ljudi.
The procedures laid down are veterinary in nature but nevertheless have the clear objective of protecting human health.
Kot poudarja pravna služba v obvestilu SJ-0811/08 z dne 2. aprila 2008, pa je treba priznati, da predlog posredno obravnava kmetijske proizvode iz Priloge I k Pogodbi in da je po mnenju Sodišča dejstvo, da ukrep zadeva proizvode iz te priloge, eden od pogojev za rabo člena 37 kot pravne podlage
However, as the Legal Service points out in its note SJ-0811/08 of 2 April 2008, it must be admitted that the proposal deals indirectly with the agricultural products listed in Annex I to the Treaty and that the Court of Justice has held that the fact that a measure concerns products listed in that Annex is one of the conditions for using Article 37 as a legal basis
Združena primera C-164/97 in C-165/97, Evropski parlament proti Svetu [1999] Poročila Sodišča Evropskih skupnosti I-1139. .
See Joined Cases C-164/97 and C-165/97 Parliament v. Council [1999] ECR - I-1139. .
Trdimo, da ta argument ni posebno močan.
It is submitted that this is not a particularly strong argument.
In čeprav pravna služba trdi, da zakonodajna praksa večinoma združuje pravni podlagi, člen 37 in člen 152(4)(b), ter da je velikokrat težko ločiti izključno kmetijske ukrepe (veterinarske in fitosanitarne ukrepe) od kmetijskih ukrepov, katerih cilj je predvsem varovati zdravje ljudi, priznava, da se z uporabo člena 37 za sprejetje takih ukrepov vračamo v sistem pred Amsterdamsko pogodbo, ko ni bilo posebnega člena Pogodbe o veterinarskih in fitosanitarnih ukrepih, in da je v nekaterih primerih zakonodajalec uporabil samo člen 152(4)(b) kot pravno podlago za ukrepe za nadzor bolezni živali ali rastlin, ki predstavljajo nevarnost za zdravje ljudi.
Again, whereas the Legal Service argues that legislative practice more often than not combines the two legal bases of Article 37 and Article 152(4)(b) and that it is often difficult to distinguish between purely agricultural (veterinary or phytosanitary measures) and agricultural measures aimed principally at protecting legal health, it concedes that the use of Article 37 for the adoption of such measures harks back to the pre-Amsterdam regime when there was no specific Treaty article on veterinary and phytosanitary measures and that in some cases the legislator has used Article 152(4)(b) alone as the legal basis for measures adopted to control a specific animal or plant disease constituting a specific danger to animal health.
Prav tako priznava, da člena 37 ni mogoče obravnavati kot absolutno nujnega za veljavnost predlaganega akta.
It also concedes that "Article 37 could not be considered as absolutely essential for the validity of the proposed act".
Kljub upoštevanju mnenja pravne službe sodimo, da ni potrebe po sklicevanju na člen 37 glede na izrecno navedeno odstopanje v členu 152(4)(b) za ukrepe na veterinarskem področju, katerih neposredni cilj je varovanje javnega zdravja.
Having duly considered the view of the Legal Service, it is nevertheless submitted that there is no need to refer to Article 37 in view of the express derogation contained in Article 152(4)(b) for measures in the veterinary field which have the protection of public health as their direct objective.
Nobenega dvoma ni, da je glede na cilj in vsebino predlagane uredbe varovanje javnega zdravja neposredni in glavni cilj ukrepa.
There is no doubt whatsoever in view of the aim and content of the proposed regulation that protection of public heath is the direct and principal objective of the measure.
Poleg tega se v zakonodajni tehniki šteje, da se je bolje izogibati uporabi več pravnih podlag, razen kadar, kot določa Sodišče, ima ukrep več sočasnih ciljev, neločljivo povezanih med seboj, pri čemer nobeden ni drugotnega pomena in posredne narave glede na ostale.
Moreover, as a matter of legislative technique, it is considered better to avoid the use of several legal bases except where, as the Court of Justice puts it, a measure has several contemporaneous objectives which are indissolubly linked with each other without one being secondary and indirect in respect to the others
Treba je upoštevati tudi dejstvo, da člen 37(2) določa postopek posvetovanja in ne soodločanja, ker to ustvarja nezdružljivost med tem členom in členom 152(4)(b).
Furthermore, the fact that Article 37(2) provides for the consultation procedure and not co-decision is also to be taken into account, since this creates an incompatibility between it and Article 152(49(b).
Čeprav pravna služba opozarja na primer titanovega dioksida
Although the Legal Service points to the Titanium Dioxide case
Zadeva C-300/89 Komisija proti Svetu [1991] Poročila Sodišča Evropskih skupnosti I-2867. , ki kaže, da pri kombinaciji pravnih podlag prevlada postopek soodločanja, se v skladu zgornjo analizo predlaga, da se ni potrebno opirati na ta precedens.
Case C-300/89 Commission v. Council [1991] ECR I-2867. as indicating that in the case of such a combined legal basis, the codecision procedure prevails, it is submitted in view of the analysis set out above, that it is unnecessary to rely on this precedent.
Zato kot pravna podlaga zadostuje člen 152(4)(b) in sklicevanje na člen 37 ni potrebno.
Consequently, Article 152(4)(b) suffices as legal basis and there is no need also to refer to Article 37.
Na seji dne 8. aprila 2008 se je Odbor za pravne zadeve odločil, soglasno
At its meeting of 8 April 2008 the Committee on Legal Affairs accordingly decided, unanimously
Pri končnem glasovanju so bili navzoči: Titus Corlăţean, predsednik; Lidia Joanna Geringer de Oedenberg, podpredsednica; Diana Wallis, pripravljavka mnenja; Sharon Bowles, Mogens Camre, Carlo Casini, Marek Aleksander Czarnecki, Bert Doorn, Vicente Miguel Garcés Ramón, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Hans-Peter Mayer, Manuel Medina Ortega, Hartmut Nassauer, Michel Rocard, Aloyzas Sakalas in Jaroslav Zvěřina. , da vam priporoči, da je ustrezna pravna podlaga za predlog 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 člen 152(4)(b) Pogodbe o ES.
The following were present for the final vote: Titus Corlăţean (acting chairman), Lidia Joanna Geringer de Oedenberg (vice-chairwoman), Diana Wallis (draftswoman), Sharon Bowles, Mogens Camre, Carlo Casini, Marek Aleksander Czarnecki, Bert Doorn, Vicente Miguel Garcés Ramón, Klaus-Heiner Lehne, Antonio Masip Hidalgo, Hans-Peter Mayer, Manuel Medina Ortega, Hartmut Nassauer, Michel Rocard, Aloyzas Sakalas and Jaroslav Zvěřina. , to recommend that the appropriate legal basis for 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 is Article 152(4)(b) of the EC Treaty.
Poročevalec načeloma pozdravlja cilje, ki jih želi doseči zadevna uredba, ter pravne predpise za izboljšano določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora.
The rapporteur welcomes in principle the objectives of the regulation, to simplify legislation improving how maximum residue limits (MRLs) of pharmacologically active substances in foodstuffs of animal origin are set.
Istočasno je treba oblikovati učinkovitejšo zaščito potrošnikov in živali ter poenostaviti postopke zaradi upoštevanja nujnih potreb, ki se v praksi vedno znova pojavljajo.
It is important at the same time to make consumer and animal protection more effective, to simplify procedures and to take due account of the urgent needs that arise repeatedly in practice.
Poročevalec pojasnjuje zlasti pogoje za možen prenos znanstveno dognanih zahtevanih spodnjih mej zaznavanja na druge živalske vrste (ekstrapolacija), saj bi to lahko pomenilo znižanje stroškov pri pridobivanju dovoljenj za zdravila, ki se uporabljajo v veterinarski medicini, sploh za uporabo v manjši meri (ovce, koze, konji).
In particular, the rapporteur clarifies the conditions for transferring scientifically identified MRLs to other species (extrapolation), as this could contribute to lowering the cost of authorising veterinary medicinal products, especially for minor areas of application (sheep, goats, horses).
Treba je sprejeti dodatne ukrepe, da se poviša kakovost in dostopnost zdravil za uporabo v manjši meri v veterinarski medicini.
Further measures should be taken to increase the quality and availability of veterinary medicinal products for minor use.
Poročevalec ima pomisleke glede prevzema najvišje dovoljene vrednosti ostankov, določenih v mednarodnem okviru (Codex Alimentarius).
The rapporteur has a number of objections as regards incorporating internationally agreed MRLs (Codex Alimentarius).
Mednarodni sporazumi na tem področju so za Evropo izjemnega pomena, saj Evropa ni samo velika uvoznica, ampak tudi ena izmed največjih izvoznic.
International agreements in this area are of great importance for Europe, which is not only a major importer but also a major exporter.
EU mora ohraniti možnost, da s specifičnimi ukrepi zagotovi zaščito potrošnika.
The EU must continue to be able to take specific measures to maintain consumer protection.
Tako kot pri drugih predlaganih poenostavitvah je vedno treba upoštevati, da je varstvo zdravja eden izmed poglavitnih ciljev Skupnosti.
As with other proposed simplifications, it must always be taken into consideration that health protection is an overriding Community objective.
Zato je treba ta cilj upoštevati pri vseh odločitvah.
Due account should therefore be taken of this objective when any decisions are made.
Ker vrednosti Codexa prejudicirajo določitev mejnih vrednosti ostankov v Skupnosti, mora Komisija, preden jih odobri, omogočiti sodelovanje Sveta in Evropskega parlamenta.
As Codex values prejudge the establishment of MRLs in the Community, the Commission must involve the Council and the European Parliament before agreement is reached.
Samodejnost prevzemanja odločitev, pri katerih javnost oziroma države članice in Evropski parlament v okviru postopka soodločanja niso bili formalno vključeni, je treba odkloniti tudi zavoljo izkušenj iz preteklosti.
Automatically incorporating decisions in which the public, Member States and the European Parliament were not formally involved via the codecision procedure should be avoided, not least in the light of previous experience.
Glede splošnih vprašanj, povezanih z vrednotenjem, je treba upoštevati, da gre pri mejnih vrednostih ostankov za živilsko zakonodajo.
As regards general issues related to assessment, account should be taken of the fact that, essentially, MRLs are of relevance to food legislation.