natgillin/translations-raw huggingface dataset:
Prisotnost snovi ali njenih ostankov v proizvodu živalskega izvora je prepovedana na podlagi mnenja v skladu s členi 4, 9 ali 10 v katerem koli od naslednjih primerov:
The presence of a substance or residues thereof in a product of animal origin shall be prohibited, pursuant to an opinion in accordance with Articles 4, 9 or 10, in either of the following circumstances:
(a) kadar kakršna koli uporaba farmakološko aktivne snovi pri živalih za proizvodnjo živil ogroža varnost zdravja ljudi;
(a) where any use of a pharmacologically active substance in food-producing animals constitutes a hazard to human health;
(a) kadar kakršna koli prisotnost farmakološko aktivne snovi ali njenih ostankov v živilih živalskega izvora predstavlja nevarnost za zdravje ljudi;
(a) where any presence of a pharmacologically active substance or residues thereof in foods of animal origin constitutes a risk to human health;
Doslednost s predlogom spremembe k členu 13(2)(d).
In keeping with the amendment to Article 13(2)(d).
Pospešeni postopek za mnenje Agencije
Accelerated procedure for an Agency opinion
V posebnih primerih, ko je treba zdravilo za uporabo v veterinarski medicini ali biocidni proizvod nujno odobriti zaradi varovanja zdravja ljudi oz. zdravja ali dobrega počutja živali, lahko Komisija, vsaka oseba, ki je zahtevala mnenje v skladu s členom 3, ali država članica Agencijo zaprosi za izvedbo pospešenega postopka za oceno mejne vrednosti ostanka farmakološko aktivne snovi, vsebovane v teh proizvodih.
In specific cases where a veterinary medicinal product or a biocidal product needs to be authorised as a matter of urgency for reasons relating to the protection of public health or of animal health or welfare, the Commission, any person who has requested an opinion pursuant to Article 3 or a Member State may ask the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit of a pharmacologically active substance contained in those products.
Obliko in vsebino vloge določi Komisija v skladu z določbami iz člena 12(1).
The format and the content of the application shall be laid down by the Commission pursuant to the provisions of Article 12(1).
Ne glede na določbe člena 9(2) in člena 8(2) Agencija zagotovi, da lahko Odbor poda svoje mnenje v 150 dneh po prejemu vloge.
Notwithstanding the provisions of Article 9(2) and Article 8(2), the Agency shall ensure that the Committee is able to issue its opinion within 150 days following receipt of the application.
Pospešeni postopek je treba uvesti za zelo nujne primere, ko se je potrebno odzvati na resno bolezen, ki je ni mogoče zdraviti z odobrenimi zdravili in ki ima resne posledice za zdravje ali dobro počutje živine.
An accelerated procedure must be established for extremely urgent cases requiring a response to a serious disease which cannot be treated with authorised medicinal products and which is having a severe impact on the health or the welfare of livestock.
Skupni postopek za določitev mejnih vrednosti ostankov bi namreč preprečeval hiter odziv na bolezen.
The joint procedure for establishing maximum residue limits would impede a swift response to the disease.
Člen 14 – odstavek 1 – pododstavek 1
Article 14 - paragraph 1 - subparagraph 1
Komisija za namen razvrstitve iz člena 13 v 30 dneh od prejema mnenja Agencije iz členov 4, 9(1) ali 10 pripravi osnutek uredbe.
For the purpose of the classification provided for in Article 13, the Commission shall prepare a draft Regulation within 30 days after receipt of the Agency's opinion referred to in Articles 4, 9(1) or 10.
Komisija prav tako pripravi osnutek uredbe v 30 dneh od prejema rezultatov glasovanja o strinjanju Skupnosti v Codex Alimentarius z določitvijo najvišjih dovoljenih vrednosti ostankov, kot določa člen 13(3).
The Commission shall also prepare a draft Regulation within 30 days after receipt of the result of a vote by the Community in favour of the establishment of a maximum residue limit in the Codex Alimentarius as referred to in Article 13(3).
Komisija prav tako pripravi osnutek uredbe v 30 dneh od prejema rezultatov glasovanja delegacije Skupnosti pri komisiji Codex Alimentarius za določitev najvišjih dovoljenih vrednosti ostankov, kot določa člen 13(3).
The Commission shall also prepare a draft Regulation within 30 days after receipt of the result of a vote by the Community Delegation at the Codex Alimentarius in favour of the establishment of a maximum residue limit as referred to in Article 13(3).
Glej predlog spremembe k členu 13, odstavek 3.
See amendment to Article 13, paragraph 3.
Člen 14 – odstavek 2
Article 14 — paragraph 2
Komisija sprejme uredbo iz odstavka 1 v skladu z regulativnim postopkom iz člena 20(2) in v 30 dneh po njegovem zaključku.
The Regulation referred to in paragraph 1 shall be adopted by the Commission in accordance with, and within 30 days after the end of the regulatory procedure referred to in Article 20(2 ).
Komisija sprejme uredbo iz odstavka 1 v skladu z regulativnim postopkom s pregledom iz člena 20(3) in v 90 dneh po njegovem zaključku.
The Regulation referred to in paragraph 1 shall be adopted by the Commission in accordance with, and within 90 days after the end of, the regulatory procedure with scrutiny referred to in Article 20(3 ).
Regulativni postopek bi bil na tem mestu ustrezen.
The regulatory procedure with scrutiny would appear to be appropriate here.
Treba je podaljšati rok, da se Evropskemu parlamentu omogoči sodelovanje.
The time period should be extended in order to allow the EP to take part adequately.
Člen 14 – odstavek 2 a (novo)
Article 14 - paragraph 2 a (new)
Komisija v primeru pospešenega postopka iz člena 13a sprejme uredbo iz odstavka 1 tega člena v 15 dneh regulativnega postopka iz člena 20(2).
In the case of the accelerated procedure referred to in Article 13a, the Commission shall adopt the Regulation referred to in paragraph 1 of this Article within 15 days of the regulatory procedure referred to in Article 20(2).
Ta odstavek je treba vključiti zaradi uvedbe nujnega postopka.
The inclusion of this paragraph is called for on account of the introduction of the emergency procedure.
Agencija se posvetuje z referenčnimi laboratoriji Skupnosti za laboratorijsko analizo ostankov, ki jih je imenovala Komisija v skladu z Uredbo (ES) št. 882/2004, o ustreznih analiznih metodah za odkrivanje ostankov farmakološko aktivnih snovi, za katere so bile določene mejne vrednosti ostankov v skladu s členom 13.
The Agency shall consult Community reference laboratories for laboratory analysis of residues designated by the Commission in accordance with Regulation (EC) No 882/2004, on appropriate analytical methods for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 13.
Agencija zagotovi navedene metode referenčnim laboratorijem Skupnosti in nacionalnim referenčnim laboratorijem, imenovanim v skladu z Uredbo (ES) št. 882/2004.
The Agency shall provide the Community reference laboratories and national reference laboratories designated in accordance with Regulation (EC) No 882/2004 with those methods.
Agencija se posvetuje z referenčnimi laboratoriji Skupnosti za laboratorijsko analizo ostankov, ki jih je imenovala Komisija v skladu z Uredbo (ES) št. 882/2004, o ustreznih analiznih metodah za usklajeno vzorčenje za odkrivanje ostankov farmakološko aktivnih snovi, za katere so bile določene mejne vrednosti ostankov v skladu s členom 13.
The Agency shall consult Community reference laboratories for laboratory analysis of residues designated by the Commission in accordance with Regulation (EC) No 882/2004, on appropriate analytical methods for harmonised sampling for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 13.
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 prepovejo uvoz in dajanje v promet živil živalskega izvora , ki vsebujejo ostanke, ki so posledica nazakonitega dajanja farmakološko aktivnih snovi, ki niso predmet razvrstitve v skladu s členom 13(2)(a), (b) ali (c).
Member States shall prohibit the import and placing on the market of food of animal origin containing residues resulting from the illegal administration of pharmacologically active substances which are not subject to a classification in accordance with Article 13(2) (a), (b) or (c).
V skladu s tem je prepovedan uvoz živil iz tretjih držav, ki vsebujejo ostanke, ki so posledica nezakonitega dajanja snovi, katerih uporaba je prepovedana v Evropski uniji.
Accordingly, imports from third countries of food containing residues resulting from the illegal administration of substances whose use is use is banned within the European Union shall be prohibited in the interests of public health.
Člen 17 – odstavek 1 – pododstavek 1 a (novo)
Article 17 — paragraph 1 — subparagraph 1 a (new)
Da se zagotovi visoka raven varovanja zdravja, se v skladu s členi 4 do 8 uporabijo načela za ocenitev tveganja.
The principles of risk assessment pursuant to Articles 4 to 8 shall be applied in order to guarantee a high level of health protection.
Člen 17 – odstavek 1 – pododstavek 3
Article 17 - paragraph 1 - subparagraph 3
Referenčne točke za ukrepe se redno preverjajo glede na tehnološki napredek .
The reference points for action shall be reviewed regularly in the light of technological progress .
Referenčne točke za ukrepe se preverjajo glede na vse nove podatke v zvezi z varovanjem zdravja ljudi in prehranjevalne verige .
The reference points for action shall be reviewed in the light of any new data concerning the protection of human health and the food chain.
Ta uredba mora biti v prvi vrsti namenjena varovanju zdravja ljudi in prehranjevalne verige in ne analitičnemu napredku.
The protection of human health and the food chain should be the first objective of this Regulation and not analytical progress.
Člen 17 – odstavek 1 – pododstavek 3 a (novo)
Article 17 — paragraph 1 — subparagraph 3 a (new)
Živila živalskega izvora, ki vsebujejo farmakološko aktivne snovi, za katere mejne vrednosti ostankov niso bile določene, se ne smejo dati v promet.
Foodstuffs of animal origin containing pharmacologically active substances for which no maximum residue limits have been set may not be placed on the market.
Lahko se domneva, da določitev po tem predpisu upošteva predvsem vidike trgovskega prava.
It is likely that decisions made under this provision will essentially be geared to trade aspects.
Tega ni treba zavrniti, vsekakor pa morajo biti tudi v takšnih primerih zagotovljena bistvena načela za oceno tveganja in varstvo zdravja.
That is not to deny per se that the essential principles of risk assessment and of health protection must continue to be guaranteed in these cases as well.
Člen 18 – odstavek 3 – pododstavek 1
Article 18 - paragraph 3 - subparagraph 1
Ocena tveganja upošteva pravila, ki jih mora Komisija sprejeti v posvetovanju z Evropsko agencijo za varnost hrane.
The risk assessment shall take account of rules to be adopted by the Commission in consultation with the European Food Safety Authority.
Ocena tveganja upošteva pravila , vključno z znanstvenimi metodami , ki jih mora Komisija sprejeti v posvetovanju z Evropsko agencijo za varnost hrane.
The risk assessment shall take account of rules including scientific methods to be adopted by the Commission in consultation with the European Food Safety Authority.
Ocena tveganja, za katero je odgovorna EFSA, zadeva znanstveno mnenje, metode in postopke.
Risk assessment which is the responsibility of EFSA concerns scientific opinion, methods and procedures.
Izraz „pravila“ je nejasen.
It is unclear what is meant by rules.
Dajanje v promet
Placing on the market
Če so mejne vrednosti ostankov ali referenčne količine, ki so bile določene v skladu s to uredbo, presežene, se proizvod ne sme dati v promet kot živilo, predelati v živilo oziroma mešati z živili.
If the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.
V primeru prekoračenja mejnih vrednosti oziroma referenčnih količin je treba predvideti pravne posledice.
There should be legal consequences for exceeding limits or reference quantities.
Prepoved trženja in mešanja bi bil primeren ukrep in nadzornim organom poenostavi odločitev na licu mesta.
A ban on marketing and mixing would appear to be the appropriate measure and relieves the inspecting authorities from making a decision on the ground.
Izvajanje referenčnih točk za ukrepe
Implementing reference points for action
Ko je opravljen nadzor nad živili živalskega izvora, rezultati analiz pa so potrdili prisotnost farmakološko aktivne snovi, ki ne spada v razvrstitev iz člena 13(2), točke (a), (b) ali (c) na enaki ali višji stopnji od praga za ukrepanje, se šteje, da zadevna živila niso v skladu z zakonodajo Skupnosti.
Where checks are carried out on food of animal origin and the results of analytical tests confirm the presence of a pharmacologically active substance which is not subject to a classification in accordance with Article 13(2 )( a), (b) or (c) at a level equal to or higher than its reference point for action, the relevant batch shall be deemed not to comply with Community legislation.
Ko so rezultati opravljenih analiz na živilih živalskega izvora pod pragom za ukrepanje, je ta živila dovoljeno vključiti v prehranjevalno verigo.
Where the results of analytical tests carried out on food of animal origin are below the reference points for action, the product's entry into the food chain shall be authorised.
Pristojni organ vodi register z rezultati za primer zavrnitve.
The competent authority shall retain a record of the findings in case of recurrence.
Ko se pri analizi proizvodov istega izvora ponavljajo rezultati, ki kažejo na potencialno težavo, pristojni organ o tem obvesti Komisijo in druge države članice v stalnem odboru za prehranjevalno verigo in zdravje živali.
Where the results of analytical tests on products from the same origin show a recurrent pattern indicating a potential problem, the competent authority shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health.
Komisija opozori na težavo pristojni organ izvorne države ali izvornih držav ter predstavi ustrezne predloge.
The Commission shall bring the matter to the attention of the competent authority of the country or countries of origin and shall submit appropriate proposals.
Podrobni ukrepi se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 21(3).
Detailed rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
Komisija v [ 60 ] dneh od začetka veljavnosti te uredbe v skladu z regulativnim postopkom iz člena 20(2) sprejme uredbo, ki vsebuje farmakološko aktivne snovi in njihovo razvrstitev glede na mejne vrednosti ostankov v skladu s prilogami I do IV Uredbe (EGS) št. 2377/90.
Within [ 60 ] days after the entry into force of this Regulation, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 20(2) , a Regulation containing the pharmacologically active substances and their classification regarding maximum residues limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
Komisija v [ 90 ] dneh od začetka veljavnosti te uredbe v skladu z regulativnim postopkom s pregledom iz člena 20(3) sprejme uredbo, ki vsebuje farmakološko aktivne snovi in njihovo razvrstitev glede na mejne vrednosti ostankov v skladu s prilogami I do IV Uredbe (EGS) št. 2377/90.
Within [ 90 ] days after the entry into force of this Regulation, the Commission shall adopt, in accordance with the regulatory procedure with scrutiny referred to in Article 20(3) , a Regulation containing the pharmacologically active substances and their classification regarding maximum residue limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
Gre za sprejetje priloge k tej uredbi.
This relates to the adoption of the annexe to this regulation.
V tem primeru je treba uporabiti regulativni postopek s pregledom.
The regulatory procedure with scrutiny should be applied in this case.
Člen 22 a (novo)
Article 22 a (new )
Poročilo Evropskemu parlamentu in Svetu
Report to the European Parliament and the Council
Komisija najpozneje pet let po začetku veljavnosti te uredbe Evropskemu parlamentu in Svetu posreduje poročilo.
The Commission shall, not later than five years after the entry into force of this Regulation, submit a report to the European Parliament and the Council.
Poročilo obravnava zlasti izkušnje, pridobljene pri uporabi te uredbe.
The report shall, in particular, review the experience gained from the application of this Regulation.
Poročilu se po potrebi priložijo ustrezni predlogi.
The report shall, if appropriate, be accompanied by relevant proposals.
Zdravila za uporabo v veterinarski medicini, ki se uporabljajo za terapevtsko zdravljenje in dobro počutje živali, namenjenih za prehrano ljudi, bi lahko povzročila prisotnost ostankov takšnih proizvodov v živalih za proizvodnjo živil.
Veterinary medicinal products used for the therapeutic treatment and the welfare of animals, which are destined for human consumption, may give rise to residues of such products in food-producing animals.
V predlagani razveljavitveni uredbi o postopku za določitev mejnih vrednosti ostankov so živali za proizvodnjo živil opredeljene kot „živali, ki so bile vzrejene, gojene ali zaklane posebej za proizvodnjo živil“.
This proposed repeal Regulation of the procedure on maximum residue levels defines food producing animals as "animals bred, raised, kept, slaughtered or harvested specifically for the purpose of the producing food."
Za zagotovitev javnega zdravja in varnosti potrošnikov je treba opraviti oceno tveganja
In order to ensure public health and consumer safety, a risk assessment
To je v skladu s trenutno veljavno Uredbo Sveta (EGS) št. 2377/90.
This is in accordance with the existing legislation Council Regulation EEC No 2377/90.
Trenutno veljavna Uredba Sveta 2377/90 določa, da se mejne vrednosti ostankov določi za vse takšne aktivne snovi, kjer je to primerno.
Existing Council Regulation 2377/90 lays down that maximum residue limits (MRLs) be established for all such active substances, where appropriate.
Predlog Komisije za razveljavitev Uredbe 2377/90 si prizadeva za rešitev težav, ki se pojavljajo pri uporabi obstoječe zakonodaje.
The Commission's proposal to repeal Regulation 2377/90 seeks to resolve the difficulties encountered in the application of this existing legislation.
V njem so predlagani še kako potrebni alternativni načini za doseganje visoke stopnje varstva potrošnikov, povezane z nadaljnjo dostopnostjo in razvojem zdravil za uporabo v veterinarski medicini za evropski trg ter dobrim delovanjem trgovine z živili živalskega izvora znotraj Skupnosti in zunaj nje.
It proposes much needed alternative ways to achieve a high level of consumer protection, coupled with the continued availability and development of veterinary medicinal products for the European market and good functioning of the intra- and extra- Community trade in food of animal origin.
Glede na to, da je končni cilj varovanje zdravja ljudi, je treba pri analizi tveganja in nadzoru ostankov farmakološko aktivnih snovi, ki se lahko pojavijo v hrani, proizvedeni v Evropski uniji ali uvoženi v Evropsko unijo, ubrati doslednejši pristop.
As the ultimate goal is human health protection, a more consistent approach is required for the risk analysis and control of residues of pharmacologically active substances, which may appear in food produced in or imported into the European Union.
Težave s trenutno veljavno zakonodajo za določanje mejnih vrednosti ostankov
Problems with the current legislation for the setting of MRLs :
Komisija pravilno poudarja, da je trenutno veljavna zakonodaja privedla do zaskrbljujočega zmanjšanja zdravil za uporabo v veterinarski medicini, in sicer „do take mere, da škodljivo vpliva na javno zdravje ter zdravje in blaginjo živali“.
The Commission rightly points out that the current legislation has led to a serious decrease in veterinary medicines "to an extent that creates adverse effects for public and animal health and animal welfare".
Odbor za zdravila za veterinarsko uporabo Evropske agencije za zdravila (EMEA) se strinja s tem, da za terapevtsko zdravljenje in dobro počutje živali ni na voljo dovolj zdravil.
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMEA), agree that there are an insufficient number of medicinal products available for the therapeutic treatment and welfare of animals.
Stanje je še posebej alarmantno pri nekaterih manj uporabljanih in manj razširjenih vrstah, kot so ovce in konji, čebele in ribe.
This is particularly alarming for certain minor use and minor species such as sheep and horses, bees and fish.
Posledica tega je veliko pomanjkanje odobrenih zdravil in naraščanje uporabe izdelkov, ki ni v skladu s povzetkom njihovih značilnosti, kar lahko ogrozi učinkovit nadzor ostankov z resnimi posledicami za varnost potrošnikov.
As a result of this, there is a major deficiency of authorised medicines and the "off-label" use of products is increasing, which may jeopardise effective residue control with serious implications for consumer safety.
Veterinarska stroka je tudi resno zaskrbljena nad čedalje večjim terapevtskim deficitom, ki je posledica izgube bistvenih snovi z dodatnimi tveganji za zdravje in dobro počutje živali, kar bi lahko ogrozilo tudi zanesljivo oskrbo prehranjevalne verige ljudi z živalskimi beljakovinami.
There is also serious concern within the veterinary profession at the increasing therapeutic void resulting from the loss of essential substances with the added risks for animal health and welfare, which may also compromise the safe supply of animal protein for the human food chain.
Druge težave, ki izhajajo iz Uredbe 2377/90:
Other problems that arise with Regulation 2377/90:
· Mednarodnih standardov, ki jih podpira EU, ni mogoče vključiti v zakonodajo Skupnosti brez nove znanstvene ocene Evropske agencije za zdravila.
· International standards supported by the EU cannot be included in Community legislation without a new scientific assessment by the European Medicines Agency.
· Nadzorne službe držav članic nimajo referenčnih točk, zlasti za snovi, odkrite v živilih iz tretjih držav.
· Control services of Member States have no points of reference in particular for substances detected in food from third countries.
· Trenutno veljavna zakonodaja je težko razumljiva.
· The current legislation is hard to follow.
Predlagana rešitev
The proposed solution:
Predlog za razveljavitev Uredbe 2377/90 obravnava pomanjkljivosti sedanjega položaja s spremembo obstoječega pravnega okvira o mejnih vrednostih ostankov, obenem pa ohranja celotni sistem določanja mejnih vrednosti ostankov na podlagi znanstvene ocene.
The proposal for repeal of Regulation 2377/90 addresses the shortcomings of the current situation by amending the existing legal framework on MRLs while leaving in place the overall system of setting MRLs based on scientific assessment.
Glavne predlagane spremembe so:
The main changes proposed are to:
· določiti oceno možnosti za ekstrapolacijo
· Make the assessment of possibilities for extrapolation