natgillin/translations-raw huggingface dataset:
Zato je treba zagotoviti, da se za presojo tveganja uporabijo enaki vidiki kot na drugih področij živilske zakonodaje.
Therefore, when it comes to the risk assessment, the same aspects as in other areas of food legislation must be taken into account.
Še posebej je treba upoštevati zaščito občutljivih skupin prebivalstva in možnost kumulativnih učinkov.
Particular consideration should be given to protecting vulnerable categories of people and the possibility of cumulative effects.
Določitev mejnih vrednosti ostankov pri snoveh, ki se ne uporabljajo v zdravilih za uporabo v veterinarski medicini, a imajo primerljiv učinek, in pri snoveh, ki se pretežno uporabljajo v tujini in pridejo k nam v promet v obliki živalskih proizvodov, je zaradi enostavnejše uporabe ter preglednosti pravil smiselna za inšpektorje.
In the interests of improving the manageability and transparency of rules for inspectors, it would appear sensible to set MRLs for substances not used in veterinary medicinal products but that have a similar effect and for substances used mainly abroad that are placed on the market here via animal products.
Trgovinski vidik in upravna poenostavitev pa bi morala biti v primerjavi z varstvom zdravja vedno drugotnega pomena.
Trade aspects and easing the administrative burden should, however, always be secondary to health protection.
Poročevalec predlaga tudi pravila o ravnanju s farmakološko aktivnimi snovmi, za katere mejne vrednosti še niso določene.
The rapporteur also proposes rules on how to treat pharmacologically active substances for which no limits have been set.
Predlogi so v glavnem skladni s prejšnjimi pravili iz uredbe (EGS) št. 315/93.
Essentially, the proposals correspond to the earlier rules laid down in Regulation (ECC) No 315/93.
Pravico Evropskega parlamenta do sodelovanja pri določitvi pravil za vrednotenje je treba zato zagotoviti v večjem obsegu, kot je predviden v predlogu Komisije.
The European Parliament’s right to be involved when rules on assessment are set must therefore be more widely applied than is proposed by the Commission proposal.
(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”);
(a) najvišje koncentracije ostanka farmakološko aktivne snovi, vsebovane v veterinarskem izdelku, ki se lahko dovoli v živilih živalskega izvora („mejna vrednost ostanka“);
(a) the maximum concentration of a residue of a pharmacologically active substance contained in a veterinary product which may be permitted in food of animal origin (“maximum residue limit”);
Snovi, na katere se nanaša ta uredba, so velika skupina, in vse so farmakološko aktivne na poseben način.
The substances affected by this regulation constitute a large group, all of them being pharmacologically active in a specific fashion.
Vendar postopki, opredeljeni v nadaljevanju tega besedila, jasno razlikujejo med snovmi, ki jih vsebujejo veterinarska zdravila, in snovmi, ki se uporabljajo v druge namene.
However, the procedures defined later in this text differentiate clearly between those contained in veterinary medicines and those intended for other uses.
Ti dve vrsti bi morali zato biti že od začetka opredeljeni kot različni.
These two types should therefore be defined as distinct entities from the outset.
Člen 1, odstavek 1, točka (a a) (novo)
Article 1, paragraph 1, point (a a) (new)
(aa) najvišje koncentracije ostanka aktivne snovi, vsebovane v biocidnih pripravkih za uporabo v živinoreji, ki so dovoljene v živilih živalskega izvora;
( aa ) the maximum concentration of a residue of an active substance contained in biocidal products used in stockbreeding which are permitted in foodstuffs of animal origin;
Snovi, na katere se nanaša ta uredba, so velika skupina, in vse so farmakološko aktivne na poseben način.
This regulation affects a large group of substances, all of them pharmacologically active in a specific fashion.
Zato je zaželeno, da se snovi, ki ne spadajo med veterinarska zdravila, uredba pa jih zadeva, posebej razmejijo.
It is therefore desirable to delimit those substances not included in veterinary medicines which are affected by it.
Zanje je bolje, da se jih imenuje „aktivne snovi“, izraz „farmakološko aktivne“ pa se prihrani za snovi, namenjene pripravi zdravil v skladu z zakonodajo Skupnosti o farmacevtskih izdelkih.
For these, it is preferable to refer to 'active substances', reserving the term 'pharmacologically active' for those intended for the preparation of medicines, in line with the Community legislation on pharmaceuticals.
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.
Da se ob upoštevanju cilja zagotovi visoka raven varovanja zdravja in ob upoštevanju načel, ki so določena v členu 6 , Odbor 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:
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 :
(a) mejnih vrednosti ostankov, določenih glede na posamezno živilo , za drugo živilo iz enake vrste,
(a) maximum residue limits established in relation to a particular foodstuff for another foodstuff derived from the same species,
(b) mejnih vrednosti ostankov, določenih glede na eno ali več vrst , za druge vrste.
(b) maximum residue limits established in relation to one or more species for other species.
V primeru ekstrapolacije med različnimi živalskimi vrstami je za določitev 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.
Ta člen določa splošne pogoje za ekstrapolacijo.
This article lays down the general conditions for extrapolation.
Jasno mora biti tudi, da mora ekstrapolacija potekati v dveh razsežnostih – med vrstami, med tkivi in med tkivi različnih vrst.
It should also be made clear that extrapolation needs to occur in 'two dimensions' - between species, between tissues and between tissues of different species.
Predlagano besedilo je v tem smislu jasnejše.
The proposed wording is more explicit in this sense.
Znanstvena ocena tveganja upošteva presnovo in izločanje farmakološko aktivnih snovi v 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 .
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).
Uporaba besede„zaužitje“ namesto besede „vnos“ je skladnejša s terminologijo, ki se uporablja na tem področju.
The use of 'ingestion' rather than 'intake' is more consistent with the terminology used in this field.
Bolje je, da govorimo o „različnih“ kot o „zadevnih“ živalskih vrstah, ker je smisel besede širši, primernost posplošenja, ki ga pomeni ekstrapolacija, pa je toliko večja, kolikor večje bo število upoštevanih živalskih vrst.
It is preferable to refer to 'different' rather than 'relevant' animal species since this is broader and the soundness of the generalisation implied by extrapolation will be the greater the larger the number of species taken into account.
(b) tveganje farmakoloških ali mikrobioloških učinkov pri ljudeh;
(b) the risk of pharmacological or microbiological effects in human beings;
Prisotnost ostankov zdravil (ali drugih snovi, zajetih v to zakonodajo) v živilih je naključna in nepredvidena.
The presence of residues of medicines (or other substances governed by this legislation) in foodstuffs is accidental and unintended.
Zato ni razloga za razlikovanje med predvidenimi in nepredvidenimi učinki, ker bodo vsi nepredvideni.
There is therefore no reason to make a distinction between intended and unintended effects, as all will be unintended.
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.
Če presnove in izločanja snovi ni mogoče oceniti, lahko znanstvena ocena tveganja upošteva podatke o spremljanju ali izpostavljenosti.
If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.
Besede „uporaba snovi pa je namenjena spodbujanju zdravja in blaginje živali“ so odveč, ker so vse zadevne snovi namenjene najmanj enemu od obeh namenov.
The words 'and the use of the substance is designed to promote animal health and welfare' are redundant, since all the substances concerned are intended for at least one of those purposes.
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;
c) Ali je treba določiti najvišjo ali začasno mejno vrednost ostanka za farmakološko aktivno snov v zdravilih za uporabo v veterinarski medicini 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, and, where appropriate, any conditions or restrictions for the use of the substance concerned;
(Prvi del ne zadeva slovenske različice).
[The first part of this amendment does not affect the English version].
Predlog spremembe črta nepotrebno specifikacijo, saj je smisel obstoja najvišjih dovoljenih vrednosti ostankov ravno prisotnost ostankov in določitev praga tolerance.
This amendment deletes an unnecessary specification, since the presence of residues and the fixing of a tolerance threshold constitute the raison d'être as such of the MRLs.
Člen 7, točka (d a) (novo)
Article 7, point (d a) (new)
(da) ali je izvedljivo predlaganje priporočil kot prispevek k določitvi karenc za druge vrste živali, namenjene za proizvodnjo hrane, kjer je potrebno uporabiti kaskadni sistem.
( da ) the feasibility of submitting recommendations aimed at contributing to establishing withdrawal periods for other food-producing species where it is necessary to use the cascade system.
(ni prevedena: predolga – glej navodila Planninga o Fdr-ju)
[ not translated: over-length - see instructions from Planning on Fdr ]
V posebnih primerih, kjer je dovoljenje nujno za zagotovitev zaščite človekovega zdravja ter zdravja in blaginje živali, lahko Komisija v skladu z regulativnim postopkom s pregledom iz člena 21(3) določi najvišjo mejno vrednost za obdobje največ pet let.
In specific cases where urgent authorisation is required to ensure the protection of human health and animal health and welfare, the Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 21(3), establish a provisional maximum residue limit for a period not exceeding five years.
V nekaterih primerih je morda potrebno izdati nujno dovoljenje za uporabo zdravil ali drugih proizvodov za boj proti boleznim živali ali za zagotovitev njihovega dobrega počutja (npr. v boju proti nosilcem novih kužnih bolezni ali pri farmakološkem zdravljenju nekaterih epidemij).
It may in some cases be necessary to proceed to an urgent authorisation for the use of medicines or other products for combating animal diseases or ensuring animal welfare (e.g. when fighting carriers of newly appeared infectious diseases or in the pharmacological treatment of certain epidemics).
Kadar to zahteva resnost položaja in da bi odvrnili veliko škodo za zdravje in dobro počutje živali, mora biti za določitev začasnih MVO na voljo začasni nujni postopek.
Where the seriousness of the situation calls for it and in order to avert major damage to animal health and welfare, an emergency procedure should be available for setting a provisional MRL.
Naslov II, Poglavje 1, oddelek 2, naslov
Title II, Chapter 1, Section 2, title
Farmakološko aktivne snovi, namenjene za uporabo v zdravilih za uporabo v veterinarski medicini
Pharmacologically active substances not intended for use in veterinary medicinal products
Farmakološko aktivne snovi, namenjene za uporabo v zdravilih za uporabo v veterinarski medicini in druge aktivne snovi, ki niso vključene v oddelek 1
Pharmacologically active substances not intended for use in veterinary medicinal products and other active substances not included in Section 1
Naslov je spremenjen skladno z drugimi predlaganimi spremembami.
The title is changed in line with other amendments tabled.
Za snovi, ki niso namenjene za uporabo v zdravilih za uporabo v veterinarski medicini, ki se dajejo na trg Skupnosti, in kadar ni bila vložena nobena vloga za takšne snovi v skladu s členom 3, lahko Komisija ali države članice posredujejo Agenciji zahtevek za mnenje o mejnih vrednostih ostankov.
For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission or Member States may forward to the Agency requests for an opinion on maximum residue limits.
Za snovi, ki niso namenjene za uporabo v zdravilih za uporabo v veterinarski medicini, ki se dajejo na trg Skupnosti, in kadar ni bila vložena nobena vloga za takšne snovi v skladu s členom 3, lahko Komisija, države članice ali tretja oseba, ki zastopa upravičene interese , posredujejo Agenciji zahtevek za mnenje o mejnih vrednostih ostankov.
For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission , Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on maximum residue limits.
Izhodiščna točka odstavka 3 je, da lahko tudi tretje osebe posredujejo zahtevke, čeprav ta možnost v odstavku 1 ni navedena.
Paragraph 3 suggests that third parties may also forward requests, although this possibility is not included in paragraph 1.
Sistematično pojasnilo.
Systematic clarification.
Člen 13, naslov
Article 13, title
Razvrstitev farmakološko aktivnih snovi
Classification of pharmacologically active substances
Razvrstitev aktivnih snovi
Classification of active substances
Usklajenost s predlogom spremembe člena 1.
This is in line with the amendments on Article 1.
Komisija razvrsti farmakološko aktivne snovi na podlagi mnenja Agencije o mejnih vrednostih ostankov v skladu s členi 4, 9 ali 10.
The Commission shall classify the pharmacologically active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10.
Komisija razvrsti aktivne snovi na podlagi mnenja Agencije o mejnih vrednostih ostankov v skladu s členi 4, 9 ali 10.
The Commission shall classify the active substances subject to an opinion of the Agency on the maximum residue limit in accordance with Articles 4, 9 or 10.
(Sprememba velja za celoten člen.
(This amendment applies to the entire article.
S sprejetjem tega člena bo treba ustrezno popraviti celotno besedilo. )
Its adoption will require technical modifications throughout the article. )
Da bi zagotovili skladnost s predlogom spremembe k členu 1(1) z dodatkom nove točke (aa) in pojasnili, da bi se ta člen moral nanašati na vse snovi iz tega člena, je zaželeno izpustiti besedo 'farmakološko'.
To ensure consistency with the amendment tabled to Article 1(1) adding a new point (aa), and to make it clear that this article should apply to all the substances cited in that Article 1, it is desirable to delete 'pharmacologically'.
Začasna mejna vrednost ostankov se lahko določi za aktivno snov, kadar so znanstveni podatki nepopolni, pod pogojem, da ni razloga za domnevo, da ostanki zadevne snovi na predlagani ravni predstavljajo tveganje za zdravje ljudi.
A provisional maximum residue limit may be established for an active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a risk to human health.
Ocena tveganja mora temeljiti na načelih v skladu s členom 6 in predpisih, sprejetih v skladu s členom 12.
The decision on risk must be based on the principles referred to in Article 6 and the rules laid down in Article 12.
Začasne mejne vrednosti ostankov se uporabljajo za obdobje, ki ne presega petih let .
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years .
Navedeno obdobje se lahko podaljša enkrat za največ dve leti, kadar je dokazano, da bi takšno podaljšanje omogočilo dokončanje tekočih znanstvenih študij.
That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow scientific studies in progress to be completed.
Začasne mejne vrednosti ostankov se uporabljajo za obdobje, ki ne presega tri leta .
The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed three years .
Najdaljše možno obdobje petih let za začasno dovoljenje se bi zdelo predolgo.
The maximum period of five years for provisional authorisation would appear too long.
Praviloma gre za snovi, ki so šle skozi postopek odobritve ali drug preskusni postopek, tako da bo zahtevane rezultate verjetno možno pridobiti v treh letih.
As a rule, the substances involved have undergone an authorisation or other test procedure, meaning that the required results would have to be available within three years.
To obdobje je daljše od obdobja za določitev vrednosti v okviru navadnega postopka.
This is a longer time period than for setting limits under the normal procedure.
Člen 13, odstavek 6, točka (a)
Article 13, paragraph 6, point (a)
(a) kadar kakršna koli uporaba aktivne snovi pri živalih za proizvodnjo živil predstavlja tveganje za zdravje ljudi;
(a) where any use of an active substance in food-producing animals constitutes a risk to human health;
Države članice ne smejo prepovedati ali ovirati uvoza in dajanja v promet živil živalskega izvora iz razlogov, povezanih z mejnimi vrednostmi ostankov, kadar se je ravnalo v skladu z določbami te uredbe in njenimi izvedbenimi ukrepi.
Member States may not prohibit or impede the import and placing on the market of food of animal origin on grounds related to maximum residue limits where the provisions of this Regulation and its implementing measures have been complied with.
Države članice ne smejo prepovedati ali ovirati uvoza in dajanja v promet živil živalskega izvora iz razlogov, povezanih z mejnimi vrednostmi ostankov ali referenčnimi točkami za ukrepe , kadar se je ravnalo v skladu z določbami te uredbe in njenimi izvedbenimi ukrepi.
Member States may not prohibit or impede the import and placing on the market of food of animal origin on grounds related to maximum residue limits or reference points for action where the provisions of this Regulation and its implementing measures have been complied with.
Uredba določa dva kazalca za zdravstvene standarde o ustreznosti živil v kontekstu prisotnosti drugih snovi, to sta MVO in referenčne točke za ukrepe.
This regulation establishes two indices related to the health standards of foodstuffs in the context of the presence of other substances, namely MRLs and reference points for action.
Živila živalskega izvora, pri katerih ni prekoračen prag ne enega ne drugega kazalca, so varna in je zanje dovoljen prost pretok, ne da bi vsebovani ostanki predstavljali kakršno koli oviro.
Foodstuffs of animal origin which do not exceed the threshold under whichever index supplies shall be considered safe and may move freely, with no obstacles related to residues.
Člen 16 bi moral obravnavati prost pretok upoštevajoč oba kazalca, ne samo MVO.
Article 16 should deal with freedom of movement in relation to both indices and not just to MRLs.
Referenčne točke za ukrepe temeljijo na vsebini analita v vzorcu, ki ga lahko odkrije in potrdi referenčni laboratorij za nadzor, imenovan v skladu z uredbo (ES) št. 882/2004, z analizno metodo, potrjeno v skladu z zahtevami Skupnosti.
The reference points for action shall be based on the content of an analyte in a sample, which can be detected and confirmed by a reference control laboratories designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated according to Community requirements.
Komisiji pri tem svetuje ustrezni referenčni laboratorij Skupnosti za izvajanje analiznih metod.
In this, the Commission shall be advised by the relevant Community reference laboratory on the performance of analytical methods.
Referenčne točke za ukrepe temeljijo na mejni vrednosti ostankov za zadevne snovi in/ali vsebini analita v vzorcu, ki ga lahko odkrije in potrdi referenčni laboratorij za nadzor, imenovan v skladu z uredbo (ES) št. 882/2004, z analizno metodo, potrjeno v skladu z zahtevami Skupnosti.
The reference points for action shall be based on the maximum residue limit for the substance concerned and/or the content of an analyte in a sample, which can be detected and confirmed by a reference control laboratory designated in accordance with Regulation (EC) No 882/2004 with an analytical method validated according to Community requirements.
Kadar zadevni odbor razmišlja o določitvi referenčne točke za ukrepe, obstaja možnost, da za nekatera tkiva ali vrste že obstaja MVO.
Where the relevant committee considers the determination of a reference point for action, it is possible that there already exists an MRL for certain tissues or species.