natgillin/translations-raw huggingface dataset:
A separate marker residue depletion study shall often also be provided, using unlabelled drug and monitoring the depletion of the marker residue in relevant food commodities over time.
Upoštevajo se navodila iz smernice 49 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih, namenjenih za proizvodnjo hrane: validacija analiznih metod, ki se uporabljajo v študijah znižanja koncentracije ostankov, da se dokažejo standardi analizne metode in pridobijo podatki o znižanju koncentracije ostanka označevalca sprejemljive kakovosti.
Total residues and marker residue data may be provided by means of a single radiolabelled study that also uses an appropriately validated non-radiolabelled method to monitor depletion of the marker residue.
Upoštevajo se posebna navodila v zvezi s študijami ostankov, ki jih je treba izvesti za snovi, namenjene uporabi pri medonosnih čebelah, ki jih vsebuje smernica 56 VICH: Študije za oceno metabolizma in kinetike ostankov zdravil za uporabo v veterinarski medicini v živalih, namenjenih za proizvodnjo hrane: priporočila glede zasnove študij ostankov v medu za določitev najvišjih mejnih vrednosti ostankov in karenc.
The test material shall contain the substance of concern in a representative concentration.
S študijo skupnih ostankov (ki se običajno izvede z izotopsko označenim zdravilom) se zagotovijo informacije o:
It shall be administered by the intended route of administration of the proposed product, at the highest intended dose and for the maximum intended duration of treatment or for the time required for steady state to be achieved in edible tissues.
znižanju koncentracije ostankov iz zadevnih živilskih surovin živali, ki so prejemale odmerke, skozi čas;
Studies shall be conducted in animals that are representative of the proposed target populations.
identiteti glavnih sestavin skupnih ostankov v zadevnih živilskih surovinah;
Guidance provided in VICH GL46: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues shall be followed in order to monitor (quantify) the depletion of total residues and key metabolites over time.
kvantitativnih razmerjih med sestavinami glavnih ostankov in skupnimi ostanki.
These studies shall normally be performed using radiolabelled drug.
Ti podatki se uporabijo za določitev ostanka označevalca in razmerja med označevalcem in skupnimi ostanki za vsako zadevno živilsko surovino.
Guidance provided in VICH GL49: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies shall be followed in order to demonstrate the analytical method standards and in order to obtain marker residue depletion data of an acceptable quality.
Opredeli se primeren ostanek označevalec.
Specific guidance relating to residue studies to be undertaken for substances intended for use in honey bees provided in VICH GL56: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods shall be followed.
To je lahko matično zdravilo, kateri koli od njegovih metabolitov ali njihova kombinacija.
The total residues study (usually performed with radiolabelled drug) shall provide information on:
Ostanek označevalec ima naslednje lastnosti:
the depletion of residues over time from relevant food commodities of treated animals;
ima znano razmerje med njim in koncentracijo skupnih ostankov v zadevnem užitnem tkivu/živilski surovini;
the identity of the major components of the total residues in relevant food commodities;
primeren je za uporabo pri testiranju za prisotnost ostankov na zadevni časovni točki;
the quantitative relationships between the major residue components and the total residues.
ima izvedljivo analizno metodo za njegovo merjenje na ravni najvišje mejne vrednosti ostankov.
These data shall be used to establish the marker residue and the ratio of marker to total residues for each relevant food commodity.
Razmerje med označevalcem in skupnimi ostanki opisuje odnos med ostankom označevalcem in skupnimi ostanki v vsaki zadevni živilski surovini.
A suitable marker residue shall be identified.
To razmerje je lahko v različnih živilskih surovinah različno, in ker se lahko s časom spreminja, se določi do trenutka, ko naj bi bili ostanki, ki vzbujajo zaskrbljenost, manjši od sprejemljivega dnevnega vnosa.
The marker residue may be the parent drug, any of its metabolites or a combination of any of these.
Razmerje med označevalcem in skupnimi ostanki se uporabi pri izračunu vnosa, da se na podlagi podatkov v zvezi z ostankom označevalcem izračuna morebitna izpostavljenost potrošnika skupnim ostankom.
The marker residue shall have the following properties:
S spremljanjem znižanja koncentracije vseh ostankov v užitnih tkivih/živilskih surovinah se določi časovna točka, na kateri se koncentracija skupnih ostankov zniža pod sprejemljivi dnevni vnos (ali del sprejemljivega dnevnega vnosa, ki je na voljo za uporabo).
it shall have a known relationship between it and the total residue concentration in the edible tissue/food commodity of interest;
V vsakem tkivu/živilski surovini se koncentracija izbranega ostanka označevalca na navedeni časovni točki upošteva kot izhodiščna točka za določitev najvišje mejne vrednosti ostankov.
it is appropriate for use in testing for the presence of residues at the time point of interest;
Informacije iz študije metabolizma omogočajo tudi primerjavo med metaboliti, ki nastanejo v ciljni živalski vrsti, in tistimi, ki nastanejo v laboratorijski živalski vrsti, s čimer se zagotovi, da so bili glavni ostanki, ki jim bodo izpostavljeni potrošniki (tj. glavni metaboliti, ki nastanejo v ciljni vrsti), ustrezno preskušeni v študijah toksičnosti pri laboratorijskih živalih.
it shall have a practicable analytical method to measure it at the level of the MRL.
Podatki o spremljanju in izpostavljenosti, če je to ustrezno
The ratio of marker to total residues describes the relationship between the marker residue and total residues in each relevant food commodity.
Podatki o spremljanju ali izpostavljenosti se za farmakološko aktivno snov ne zahtevajo.
This ratio may be different in different food commodities and, as it may vary over time, it shall be established until the time corresponding to that at which residues of concern are expected to be below the ADI.
Če pa so na voljo, lahko v nekaterih primerih zagotavljajo dragocene dodatne informacije, tj. za snovi, ki so že prisotne v okolju (bodisi naravno bodisi ker se uporabljajo v veterini ali drugih panogah).
The ratio of marker to total residues shall be used in the intake calculation to calculate potential consumer exposure to total residues from data relating to the marker residue.
Taki podatki so lahko koristni pri določanju osnovnih vrednosti, ki so jim potrošniki morda že izpostavljeni.
By monitoring the depletion of total residues in the edible tissues/food commodities, the time point at which total residues deplete to below the ADI (or the fraction of the ADI available for use) shall be established.
Če so taki podatki na voljo, bodisi kot objavljeni rezultati uradnih organov za spremljanje ostankov bodisi kot rezultati akademskih ali drugih raziskav, se navedejo.
In each tissue/food commodity, the concentration of the selected marker residue at this time point shall be taken as the starting point from which the MRL shall be developed.
Analizna metoda za ostanke
Information from the metabolism study shall also allow comparison of the metabolites produced in the target animal species with those produced in the laboratory animals species in order to ensure that the major residues to which consumers will be exposed (i.e. the major metabolites produced in the target species) were adequately tested in the laboratory animal toxicity studies.
Predloži se validacijsko poročilo o analizni metodi, uporabljeni za količinsko določitev ostanka označevalca v študiji ostankov.
Monitoring and exposure data, if relevant
Z validacijo se dokaže, ali analizna metoda izpolnjuje merila, ki veljajo za ustrezne značilnosti učinkovitosti.
Monitoring or exposure data of the pharmacologically active substance shall not be required.
Upoštevajo se posebna navodila za validacijo analiznih metod iz smernice 49 VICH.
However, if available, it may provide valuable additional information in certain cases, i.e. for substances that are already present in the environment (either naturally or as a result of use in the veterinary or other sectors).
Analizne metode se zagotovijo vsaj za tiste živilske surovine in vrste, pri katerih se zahtevajo najvišje mejne vrednosti ostankov.
Such data may be useful in determining background levels to which consumers may already be exposed.
Potrdi se razpoložljivost standardov in zagotovijo kontaktni podatki, da se po potrebi omogoči izmenjava informacij med predstavniki osebja referenčnega laboratorija EU in nacionalnega referenčnega laboratorija ter podjetjem.
If such data are available, whether as published results from official residue monitoring bodies or as results of academic or other research, these shall be provided.
Vsak odmik od zgoraj navedenih zahtev se utemelji, njegov vpliv pa se obravnava.
Residue analytical method
Analizna metoda se oceni glede skladnosti s smernico 49 VICH in dodatnimi točkami, poudarjenimi zgoraj.
A validation report of the analytical method used for quantification of the marker residue in the residues study shall be provided.
Poleg tega se agencija posvetuje z evropskim referenčnim laboratorijem za nadzor nad ostanki za posamezno vrsto snovi glede ustreznosti razpoložljivih metod in validacijskih podatkov.
Validation shall demonstrate that the analytical method complies with the criteria applicable for the relevant performance characteristics.
Na podlagi mnenja agencije se lahko validacijski podatki delijo z drugimi referenčnimi laboratoriji EU in nacionalnimi referenčnimi laboratoriji, da se zadevnim organom olajša razvoj ustreznih metod.
The specific guidance on validation of analytical methods is provided in VICH GL49 shall be followed.
Potencialni učinki na mikroorganizme, ki se uporabljajo v industrijski predelavi živil
Analytical methods shall be provided at least for those food commodities and species in which MRLs are requested.
Ocena ostankov vključuje oceno potencialnih učinkov mikrobiološko aktivnih ostankov na mikroorganizme, ki se uporabljajo v industrijski predelavi živil, zlasti kar zadeva proizvodnjo mlečnih izdelkov.
The availability of standards shall be confirmed and contact details provided in order to allow an exchange of information, if necessary, between representatives of the EU and national reference laboratory staff and the company.
Podatki se uporabijo za določitev koncentracije ostankov brez vpliva na starterske kulture.
Any departures from the requirements above shall be justified and the impact discussed.
To se upošteva pri izpeljavi najvišjih mejnih vrednosti ostankov, s čimer se zagotovi, da ostanki v zadevnih živilskih surovinah (tj. mleku) niso prisotni na ravneh, ki vplivajo na mlečne starterske kulture.
The analytical method shall be evaluated for compliance with VICH GL49 and the additional points raised above.
V študijah, ki se izvedejo, se upoštevajo smernice agencije za oceno učinka antimikrobičnih snovi na mlečne starterske kulture.
In addition, the Agency shall consult the European Reference Laboratory for control of residues for the particular substance type on the adequacy of the available methods and validation data.
Če se preskušanje mikroorganizmov, ki se uporabljajo v industrijski predelavi živil, ne izvede, se neobstoj takih podatkov znanstveno utemelji, posledice njihovega neobstoja pa se obravnavajo.
Following the Agency's opinion, the validation data may be shared with other EU and national reference laboratories in order to facilitate development of appropriate methods by those authorities.
Če so ustrezne ocene ostankov snovi izvedli drugi znanstveni organi EU ali mednarodni znanstveni organi, vključno z EFSA, ECHA, JECFA in skupnimi sejami o ostankih pesticidov, se to navede skupaj z njihovimi ugotovitvami.
Potential effects on the microorganisms used for industrial food processing
Direktiva 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi (UL L 50, 20.2.2004, str. 44).
The residues evaluation shall include an assessment of the potential effects of microbiologically active residues on microorganisms used for industrial food processing, in particular as regards the manufacture of dairy products.
Direktiva 2010/63/EU Evropskega parlamenta in Sveta z dne 22. septembra 2010 o zaščiti živali, ki se uporabljajo v znanstvene namene (UL L 276, 20.10.2010, str. 33).
The data shall be used to establish a residue concentration without effect on starter cultures.
Uredba (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 152, 16.6.2009, str. 11).
This shall be taken into consideration when deriving MRLs, to ensure that residues present in relevant food commodities (i.e. milk) are not present at levels that impact on dairy starter cultures.
Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (Zahteve za podatke o varnosti in ostankih zdravil za uporabo v veterinarski medicini, namenjenih za manj pomembne uporabe ali za manj pomembne vrste/omejen trg, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38).
The studies to be performed shall follow Agency's guidance for the assessment of the effect of antimicrobial substances on dairy starter cultures.
Izvedbena uredba Komisije (EU) 2017/12 z dne 6. januarja 2017 glede oblike in vsebine vlog in zahtevkov za določitev mejnih vrednosti ostankov v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta (UL L 4, 7.1.2017, str. 1).
If no testing of microorganisms used for industrial food processing is undertaken, the absence of such data shall be scientifically justified and the impact of its absence discussed.
Pristop k določitvi farmakološkega sprejemljivega dnevnega vnosa (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=).
If relevant residues evaluations of the substance have been undertaken by other EU or international scientific bodies including EFSA, ECHA, JECFA and JMPR this shall be presented, along with the conclusions reached.
VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing (smernica 37 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: testiranje (dolgoročne) toksičnosti s ponovljenim odmerkom, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37).
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree (Pregled pristopa s pragom toksikološkega tveganja in oblikovanje novega drevesa odločanja za ta prag, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/epdf).
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Smernica OECD za preskušanje št. 424: Študija nevrotoksičnosti pri glodalcih (http://www.oecd-ilibrary.org/environment/test-no-424-neurotoxicity-study-in-rodents_9789264071025-en).
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Smernica OECD za preskušanje št. 426: Študija razvojne nevrotoksičnosti (http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en).
Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001536.jsp&mid=WC0b01ac058002dd38).
Smernica OECD za preskušanje št. 443: Razširjena študija enogeneracijske reproduktivne toksičnosti (http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en).
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ L 4, 7.1.2017, p. 1).
Smernica OECD za preskušanje št. 418: Zapoznela nevrotoksičnost organofosfornih snovi po akutni izpostavljenosti (http://www.oecd-ilibrary.org/environment/test-no-418-delayed-neurotoxicity-of-organophosphorus-substances-following-acute-exposure_9789264070905-en).
Approach to establish a pharmacological acceptable daily intake (ADI) (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001530.jsp&mid=).
Smernica OECD za preskušanje št. 419: Zapoznela nevrotoksičnost organofosfornih snovi – 28-dnevna študija s ponovljenim odmerkom (http://www.oecd-ilibrary.org/environment/test-no-419-delayed-neurotoxicity-of-organophosphorus-substances-28-day-repeated-dose-study_9789264070929-en).
VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001481.jsp&mid=WC0b01ac058002dd37).
VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI (smernica 36 VICH: Študije za oceno varnosti ostankov zdravil za uporabo v veterinarski medicini v živilih: splošni pristop za določitev mikrobiološkega sprejemljivega dnevnega vnosa, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001531.jsp&mid=WC0b01ac058002dd37).
Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree (http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2016.EN-1006/epdf).
Smernice znanstvenega odbora o uporabi pristopa s primerjalnim odmerkom pri oceni tveganja (http://www.efsa.europa.eu/en/efsajournal/pub/1150).
OECD Test No 424: Neurotoxicity Study in Rodents (http://www.oecd-ilibrary.org/environment/test-no-424-neurotoxicity-study-in-rodents_9789264071025-en).
Smernice za oceno učinka antimikrobičnih snovi na mlečne starterske kulture (http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500004533&mid=WC0b01ac058009a3dc).
OECD Test No 426: Developmental Neurotoxicity Study (http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en)
PRILOGA II
OECD Test No 443: Extended One-Generation Reproductive Toxicity Study (http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264185371-en).
Metodološka načela priporočil za obvladovanje tveganja iz člena 7 Uredbe (ES) št. 470/2009
OECD Test No 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (http://www.oecd-ilibrary.org/environment/test-no-418-delayed-neurotoxicity-of-organophosphorus-substances-following-acute-exposure_9789264070905-en).
I. DOLOČITEV NAJVIŠJIH MEJNIH VREDNOSTI OSTANKOV
OECD Test No 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (http://www.oecd-ilibrary.org/environment/test-no-419-delayed-neurotoxicity-of-organophosphorus-substances-28-day-repeated-dose-study_9789264070929-en).
Izpeljava številčnih najvišjih mejnih vrednosti ostankov
VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001531.jsp&mid=WC0b01ac058002dd37).
Kadar se v skladu s to uredbo šteje ustrezno določiti številčne najvišje mejne vrednosti ostankov, se najvišje mejne vrednosti ostankov navadno priporočijo za naslednja užitna tkiva:
Guidance of the Scientific Committee on Use of the benchmark dose approach in risk assessment (http://www.efsa.europa.eu/en/efsajournal/pub/1150).
za sesalce, razen prašičev: mišičje, maščevje, jetra in ledvice;
Note for guidance for the assessment of the effect of antimicrobial substances on diary starter cultures (http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500004533&mid=WC0b01ac058009a3dc).
za prašiče in perutnino: mišičje, maščevje in kožo v naravnem razmerju, jetra in ledvice;
ANNEX II
za ribe: koža in mišičje v naravnem razmerju;
Methodological principles for the risk management recommendations referred to in Article 7 of Regulation (EC) No 470/2009
če je snov predlagana za uporabo pri vrstah, ki proizvajajo mleko, jajca ali med, se najvišje mejne vrednosti ostankov po možnosti priporočijo za mleko, jajca in/ali med.
I. ELABORATION OF MRLs
Kar zadeva tkiva, priporočila za najvišje mejne vrednosti ostankov v mleku, jajcih in medu temeljijo na podatkih, ki kažejo profil znižanja koncentracije ostankov v teh živilih.
Derivation of numerical MRLs
Kadar taki podatki niso na voljo, je morda treba neporabljeni del sprejemljivega dnevnega vnosa nameniti za prihodnjo določitev najvišjih mejnih vrednosti ostankov v teh živilih (oddelek II.5).
Where it is considered appropriate in accordance with this Regulation to establish numerical MRL values, MRLs shall routinely be recommended for the edible tissues listed below:
Pri določitvi najvišjih mejnih vrednosti ostankov je treba upoštevati naslednje:
for mammals other than swine: muscle, fat, liver and kidney;
sprejemljivi dnevni vnos (ali alternativno omejitev, če je primerno) – najvišje mejne vrednosti ostankov se priporočijo na ravneh, ki zagotavljajo, da izpostavljenost potrošnikov ostankom, ki vzbujajo zaskrbljenost, ostane pod sprejemljivim dnevnim vnosom;
for swine and poultry: muscle, fat and skin in natural proportions, liver and kidney;
predlagani ostanek označevalec;
for fin-fish: muscle and skin in natural proportions;
razmerje med ostankom označevalcem in skupnimi ostanki;
if the substance is proposed for use in a milk producing, egg producing or honey producing species, MRLs shall be recommended for milk, eggs and/or honey, respectively, wherever possible.
porazdelitev ostankov v užitnih tkivih – pri posameznih najvišjih mejnih vrednostih ostankov, predlaganih za različna užitna tkiva, se upošteva porazdelitev ostankov po teh tkivih.