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1–23/23
toxicological assessment
1 Objavljeno
RS
Ur. l. RS, št. MP 2004-32
(b) Hazard assessment for the endpoint or endpoints of concern, including a consideration of toxicological interactions involving multiple chemicals;
(b) oceno nevarnih lastnosti za ciljni učinek ali ciljne učinke, ki vzbujajo skrb, vključno z upoštevanjem toksikoloških interakcij, pri katerih nastopa več kemikalij;
2 Pravna redakcija
DRUGO
In its proposal, the Commission shall take account of existing technical and scientific knowledge on the matter and in particular data submitted by the Member States with an interest, especially the toxicological assessment and estimated ADI, good agricultural practice and the trial data which the Member State of origin used to establish the maximum residue level, together with the reasons given by the Member State of destination for deciding on the measures in question.
V svojem predlogu Komisija upošteva tehnična in znanstvena spoznanja o zadevi in zlasti podatke, ki jih predložijo zainteresirane države članice, posebej presojo o toksičnosti in ocenjene ADI, dobro kmetijsko prakso in podatke iz poskusov, ki jih je država članica izvora uporabila pri določitvi mejne vrednosti ostanka, skupaj z razlogi, ki jih poda namembna država članica o izbiri zadevnih ukrepov.
3 Pravna redakcija
finance
CELEX: 32003L0063
Except for biological medicinal products, an assessment of the impurities and degradation products shall be included along with their potential pharmacological and toxicological effects.
Vključi se, razen pri bioloških zdravilih, ocena nečistot in razpadnih produktov skupaj z njihovimi potencialnimi farmakološkimi in toksikološkimi učinki.
4 Pravna redakcija
finance
CELEX: 32004L0004
(3) In the case of cyclohexanol, 2,3-butanediol, iso-butanol and nonane, the information available was inadequate or needed additional clarification to allow a sound scientific assessment of the toxicological properties and the Scientific Committee on Food was unable to carry out the requested evaluations.
(3) Znanstveni odbor za prehrano ni mogel opraviti zahtevanih vrednotenj za cikloheksanol, butan-2,3-diol, izobutanol in nonan, ker so bili razpoložljivi podatki neustrezni ali bi pravilna znanstvena ocena toksikoloških lastnosti potrebovala dodatno pojasnitev.
5 Pravna redakcija
finance
CELEX: 32003R2065
(8) The Scientific Committee on Food concluded that because of the wide physical and chemical differences in smoke flavourings used for flavouring food, it is not possible to design a common approach to their safety assessment and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates.
(8) Znanstveni odbor za prehrano je sklenil, da zaradi velikih fizikalnih in kemičnih razlik v aromah dima, ki se uporabljajo za aromatiziranje živil, ni možno oblikovati enotnega pristopa k ocenjevanju njihove varnosti in se mora skladno s tem toksikološka ocena osredotočiti na varnost posameznih dimnih kondenzatov.
6 Pravna redakcija
DRUGO
Whereas, after scientific assessment by the Committee for Veterinary Medicinal Products, maximum residue levels must be adopted by a rapid procedure which ensures close cooperation between the Commission and the Member States through the Committee set up under Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (4), as last amended by Directive 87/20/EEC (5);
ker je treba po znanstveni presoji, ki jo opravi Odbor za zdravila za uporabo v veterinarski medicini, sprejeti najvišje dovoljene količine zaostankov po hitrem postopku, ki zagotavlja tesno sodelovanje med Komisijo in državami članicami v odboru, ustanovljenim na podlagi Direktive Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaj držav članic v zvezi z analiznimi, farmako-toksikološkimi in kliničnimi standardi ter protokoli za preskušanje zdravil za uporabo v veterinarski medicini fn, kakor je bila nazadnje spremenjena z Direktivo 87/20/EGS fn;
7 Prevajalska redakcija
izobraževanje
CELEX: 31996D0158
the assessment of the health (toxicological) effects of the product if its is to be used for human food or animal feed, and
oceno (toksikoloških) učinkov proizvoda na zdravje, če se bo proizvod uporabil za hrano za ljudi ali živalsko krmo, in
8 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
All available biological data and information which is relevant to the assessment of the toxicological profile of the substance tested, must be reported.
Predložiti je treba vse dostopne biološke podatke in informacije, pomembne za oceno toksikološkega profila testirane snovi.
9 Prevajalska redakcija
izobraževanje
CELEX: 32003L0068
In its assessment of the new data the Committee concluded that those polar compounds will not cause an unacceptable ecotoxicological or toxicological risk.
V svoji oceni novih podatkov je odbor sklenil, da navedene polarne spojine ne bodo povzročale nesprejemljivih ekotoksikoloških ali toksikoloških tveganj.
10 Prevajalska redakcija
izobraževanje
CELEX: 31999L0045
that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.
dokazati, da bi zaradi pojavov, kot je na primer nasprotno delovanje, običajno ocenjevanje precenilo toksikološko nevarnost, se taki pojavi upoštevajo pri razvrstitvi pripravka.
11 Prevajalska redakcija
izobraževanje
CELEX: 31999L0045
that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,
dokazati, da bi običajno ocenjevanje zaradi pojavov, kot je okrepitev delovanja, podcenilo toksikološko nevarnost, se taki pojavi upoštevajo pri razvrstitvi pripravka,
12 Prevajalska redakcija
izobraževanje
CELEX: 31993L0067
Whereas, having regard to its classification in accordance with Directive 67/548/EEC, the assessment of risks to man should take account of the physico-chemical and toxicological properties of a substance;
ker bi bilo treba ob upoštevanju razvrstitve snovi v skladu z Direktivo 67/548/EGS pri ocenjevanju tveganja za človeka upoštevati njene fizikalno-kemijske in toksikološke lastnosti;
13 Prevajalska redakcija
izobraževanje
CELEX: 31999L0045
whereas, therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals;
ker se potemtakem po tej direktivi uporabljajo samo že znani rezultati ugotavljanj toksikoloških in ekotoksikoloških značilnosti; ker ta direktiva ne nalaga nobene obveznosti za izvajanje dodatnih poskusov na živalih.
14 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use.
Pridobiti je treba dovolj informacij in podatkov ter jih predložiti za oceno obsega izpostavljenosti aktivni(m) snovi(em) in/ali toksikološko pomembnim sestavinam v fitofarmacevtskem sredstvu, ki se lahko pojavijo v predlaganih pogojih uporabe.
15 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
The clinical trial subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior to any clinical trial, screening by ethics committees and Member States' competent authorities, and rules on the protection of personal data.
Zaščito preizkušancev kliničnega preskušanja zagotavljajo ocena tveganja, ki temelji na rezultatih toksikoloških poskusov pred kakršnim koli kliničnim preskušanjem, pregled odborov za etiko in pristojnih organov držav članic ter pravila o varstvu osebnih podatkov.
16 Prevajalska redakcija
izobraževanje
CELEX: 32004L0004
In the case of cyclohexanol, 2,3-butanediol, iso-butanol and nonane, the information available was inadequate or needed additional clarification to allow a sound scientific assessment of the toxicological properties and the Scientific Committee on Food was unable to carry out the requested evaluations.
Znanstveni odbor za prehrano ni mogel opraviti zahtevanih vrednotenj za cikloheksanol, butan-2,3-diol, izobutanol in nonan, ker so bili razpoložljivi podatki neustrezni ali bi pravilna znanstvena ocena toksikoloških lastnosti potrebovala dodatno pojasnitev.
17 Prevajalska redakcija
izobraževanje
CELEX: 32003R2065
The Scientific Committee on Food concluded that because of the wide physical and chemical differences in smoke flavourings used for flavouring food, it is not possible to design a common approach to their safety assessment and, accordingly, toxicological evaluation should focus on the safety of individual smoke condensates.
Znanstveni odbor za prehrano je sklenil, da zaradi velikih fizikalnih in kemičnih razlik v aromah dima, ki se uporabljajo za aromatiziranje živil, ni možno oblikovati enotnega pristopa k ocenjevanju njihove varnosti in se mora skladno s tem toksikološka ocena osredotočiti na varnost posameznih dimnih kondenzatov.
18 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment.
Študije, v katerih se uporabljajo aktivne snovi, proizvedene v laboratoriju ali v poskusni proizvodnji, je treba ponoviti z aktivno snovjo iz proizvodnje, razen kadar je mogoče utemeljiti, da je uporabljena testirana snov s stališča toksikološkega testa in ocene enaka.
19 Prevajalska redakcija
izobraževanje
CELEX: 31994L0079
Where relevant, in the light of findings with respect to the analytical profile of batches of the active substance (paragraph 1.11) and any bridging studies conducted (paragraphs 5 (iv)), the relevance of the data as submitted to the assessment of the toxicological profile of the active substance as manufactured, must be argued.
Kadar je to primerno, je treba z vidika ugotovitev v zvezi z analitskimi lastnostmi serij aktivne snovi (odstavek 1.11) in morebitnimi povezovalnimi študijami (odstavek 5.(iv)), dokazati ustreznost podatkov, predloženih za oceno toksikoloških lastnosti tehnične aktivne snovi.
20 Prevajalska redakcija
izobraževanje
CELEX: 32003L0074
As regards the other five hormones (testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate), the SCVPH assessment is that, in spite of the individual toxicological and epidemiological data available, which were taken into account, the current state of knowledge does not make it possible to give a quantitative estimate of the risk to consumers.
Glede ostalih petih hormonov (testosterona, progesterona, trenbolon acetata, zeranola in melengestrol acetata) SCVPH ocenjuje, da kljub posameznim razpoložljivim toksikološkim in epidemiološkim podatkom, ki so bili upoštevani, na podlagi trenutnega poznavanja stanja ni mogoče izdelati kvantitativne ocene tveganja za potrošnike.
21 Prevajalska redakcija
izobraževanje
CELEX: 31999L0045
by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,
z epidemiološkimi raziskavami, z znanstveno preverjenimi študijami primerov v skladu s Prilogo VI k Direktivi 67/548/EGS ali s statistično podprtimi izkušnjami, kot je vrednotenje podatkov iz enot za zbiranje informacij o zastrupitvah ali podatkov o poklicnih boleznih, dokazati, da se toksikološki učinki na ljudi razlikujejo od učinkov, ugotovljenih s pomočjo metod iz odstavka 1, potem se pripravek razvrsti skladno s svojimi učinki na ljudi,
22 Prevajalska redakcija
izobraževanje
CELEX: 31995L0036
Introduction (i) The information provided, taken together with that for one or more preparations containing the active substance, must be sufficient to pemit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance.
Uvod (i) Predložene informacije, skupaj s podatki za enega ali več pripravkov, ki vsebujejo aktivno snov, morajo zadoščati za oceno vpliva in obnašanja aktivne snovi v okolju in oceno možne ogroženosti neciljnih vrst zaradi izpostavljenosti aktivni snovi, njenim metabolitom, razgradnim in reakcijskim produktom, kadar so toksikološko ali okoljsko pomembni.
23 Prevajalska redakcija
izobraževanje
CELEX: 31994R1488
Whereas, having regard to the classification of a given substance in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (2), as last amended by Commission Directive 93/105/EC (3), the assessment of risks to man should take account of the physico-chemical and toxicological properties of a substance;
ker bi ob upoštevanju razvrščanja določene snovi v skladu z Direktivo Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi[2], kakor je bila nazadnje spremenjena z Direktivo Komisije 93/105/ES[3], ocena tveganja za človeka morala upoštevati fizikalno-kemijske in toksikološke lastnosti snovi;
Prevodi: en > sl
1–23/23
toxicological assessment