natgillin/translations-raw huggingface dataset:
The mixture of milk and antigens must be incubated at 37 °C for 60 minutes, together with positive and negative working standards.
Mešanico mleka in antigenov je treba 60 minut inkubirati na 37 °C skupaj s pozitivnimi in negativnimi delovnimi standardi.
A subsequent 16- to 24-hours incubation at 4 °C increases the sensitivity of the test.
Nadaljnja inkubacija za 16 do 24 ur na 4 °C poveča občutljivost testa.
Interpretation of results:
Razlaga rezultatov:
negative reaction: coloured milk, colourless cream;
negativna reakcija: obarvano mleko, neobarvana smetana;
positive reaction:
pozitivna reakcija:
identically coloured milk and cream, or
enako obarvana mleko in smetana, ali
colourless milk and coloured cream.
neobarvano mleko in obarvana smetana.
Buffered Brucella antigen test (Rose Bengal test (RBT))
Brucella antigen test v pufru (rose bengal test (RBT)
The antigen represents a bacterial suspension in buffered Brucella antigen diluent at a pH of 3,65 ± 0,05, stained by the use of rose Bengal dye.
Antigen je suspenzija bakterij v puferirani raztopini za razredčevanje Brucella antigena s pH 3,65 ± 0,05, obarvana z rose bengal barvilom.
The antigen shall be delivered ready for use and must be stored at 4 °C and not frozen.
Antigen se dostavi pripravljen za uporabo, nakar ga je treba hraniti na 4 °C in ne zamrzovati.
The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces a positive reaction with a serum dilution of 1/45 and a negative reaction with a dilution of 1/55.
Antigen se pripravi ne glede na koncentracijo celic, njegova občutljivost pa mora biti standardizirana glede na OIEISS tako, da antigen povzroči pozitivno reakcijo z razredčino seruma 1/45 in negativno reakcijo z razredčino 1/55.
The RBT shall be carried out in the following manner:
RBT se izvaja na naslednji način:
serum (20-30 μl) is mixed with an equal volume of antigen on a white tile or enamel plate to produce a zone approximately 2 cm in diameter.
serum (20–30 μl) se pomeša z enakim volumnom antigena na beli keramični ploščici ali plošči iz emajla, da nastane področje s premerom približno 2 cm.
The mixture is rocked gently for four minutes at ambient temperature, and then observed in a good light for agglutination;
Mešanica se na sobni temperaturi nežno ziblje 4 minute, potem pa pri dobrih svetlobnih pogojih opazuje, ali se pojavi aglutinacija;
an automated method may be used but must be at least as sensitive and accurate as the manual method.
uporabi se lahko avtomatizirana metoda, ki pa mora biti vsaj tako občutljiva in točna kot ročna metoda.
Any visible reaction shall be considered to be positive, unless there has been excessive drying round the edges.
Kakršna koli vidna reakcija se pojmuje kot pozitivna, razen če je prišlo ob robovih do pretirane izsušitve.
Positive and negative working standards shall be included in each series of tests.
Pri vsaki seriji testov se vključijo pozitivni in negativni delovni standardi.
Serum agglutination test (SAT)
Seroaglutinacijski test (SAT)
The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85 % (m/v) and phenol at 0,5 % (v/v)).
Antigen je suspenzija bakterij v fiziološki raztopini s fenolom (koncentracija NaCl 0,85 % in volumski delež fenola 0,5 %).
Formaldehyde must not be used.
Formaldehida se ne sme uporabljati.
EDTA may be added to the antigen suspension to 5 mM final test dilution to reduce the level of false positives to the serum agglutination test.
Suspenziji antigena se lahko doda EDTA do 5 mM v končni testni razredčini, da se zmanjša število lažnih pozitivnih rezultatov seroaglutinacijskega testa.
Subsequently the pH of 7.2 must be readjusted in the antigen suspension.
Naknadno je treba korigirati pH suspenzije antigena na pH 7,2.
The OIEISS contains 1000 international units of agglutination.
OIEISS vsebuje 1000 internacionalnih enot aglutininov.
The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces either a 50 % agglutination with a final serum dilution of 1/600 to 1/1000 or 75 % agglutination with a final serum dilution of 1/500 to 1/750.
Antigen se pripravi ne glede na koncentracijo celic, njegova občutljivost pa mora biti standardizirana glede na OIEISS tako, da antigen povzroči 1/600 do 1/1000 ali 75 % aglutinacijo s končno razredčino seruma 1/500 do 1/750.
It may also be advisable to compare the reactivity of new and previously standardised batches of antigen using a panel of defined sera.
Priporočljivo bi bilo tudi primerjati reaktivnost novih in prej standardiziranih serij antigena ob pomoči serije definiranih serumov.
The test shall be performed either in tubes or in microplates.
Test se naredi v epruvetah ali na mikroploščah.
The mixture of antigen and serum dilutions shall be incubated for 16- to 24-hours at 37 °C.
Mešanico antigena in razredčin seruma se inkubira za 16 do 24 ur na 37 °C.
At least three dilutions must be prepared for each serum.
Za vsak serum je treba pripraviti vsaj tri razredčine.
Dilutions of suspect serum must be made in such a way that reading of the reaction at the positivity limit is made in the median tube (or well for the microplate method).
Razredčine preiskovanega seruma je treba narediti tako, da se reakcija na meji pozitivnosti odčita v sredinski epruveti (ali vdolbini pri metodi z mikroploščo).
The degree of Brucella agglutination in a serum must be expressed in IU per ml.
Stopnja aglutinacije brucel v serumu mora biti izražena v IE na ml.
A serum containing 30 or more IU per ml is considered to be positive.
Serum, ki vsebuje 30 ali več IE na ml, se pojmuje kot pozitiven.
Fluorescence polarisation assay (FPA)
Test s fluorescentnimi označevalci (FPA)
The FPA can be performed in glass tubes or a 96-well plate format.
FPA se lahko naredi v steklenih epruvetah ali na mikroploščah s 96 vdolbinami.
The technique used, its standardisation and the interpretation of results must conform to that specified Chapter 2.4.3 (bovine brucellosis) of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.
Uporabljene tehnike, njihova standardizacija in razlaga rezultatov morajo biti v skladu s tistimi, opredeljenimi v Priročniku za diagnostične teste in cepiva za kopenske živali OIE, šesta izdaja, 2008, poglavje 2.4.3 (goveja bruceloza).
The FPA shall be standardised so that:
FPA se standardizira, da:
the OIEELISASPSS and OIEELISAWPSS consistently give positive results.
OIEELISASPSS in OIEELISAWPSS dosledno dajeta pozitivni rezultat;
a 1/8 pre-dilution of the OIEELISAWPSS or a 1/64 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) always gives a negative reaction;
predrazredčina 1/8 OIEELISAWPSS ali predrazredčina 1/64 OIEELISASPSS v negativnem serumu (ali negativnem skupinskem vzorcu serumov) vedno dasta negativno reakcijo;
the OIEELISANSS always gives a negative reaction.
OIEELISANSS vedno da negativno reakcijo.
The following shall be included in each batch of tests: a strong positive, a weak positive, a negative working standard serum (calibrated against the OIE ELISA Standard Sera).
V vsako serijo testov se vključi naslednje: močan pozitivni, šibek pozitivni, negativni delovni standardni serum (kalibriran glede na OIE EISA standardne serume).
COMPLEMENTARY TESTS
DOPOLNILNI TESTI
Brucellosis skin test (BST)
Intrakutani test za brucelozo (Brucellosis skin test – BST)
Conditions for the use of BST
Pogoji za uporabo BST
The brucellosis skin test shall not be used for the purpose of certification for intra-Community trade.
Intrakutani test za brucelozo se ne uporablja v namene certificiranja za trgovino znotraj Skupnosti.
The brucellosis skin test is one of the most specific tests for the detection of brucellosis in unvaccinated animals; however diagnosis must not be made on the basis of positive intradermal reactions alone.
Intrakutani test za brucelozo je eden najbolj specifičnih testov za zaznavanje bruceloze pri necepljenih živalih; vendar pa diagnoze samo na podlagi pozitivnih intradermalnih reakcij ne smemo postavljati.
Bovine animals, tested with negative result in one of the serological tests defined in this Annex and reacting positively to the BST shall be regarded as infected or suspected to be infected.
Govedo, ki je bilo v enem od seroloških testov iz te priloge negativno in ki reagira pozitivno na BST, se pojmuje kot okuženo ali za katero se sumi, da je okuženo.
Bovine animals, tested with positive result in one of the serological tests defined in this Annex may be subject to a BST in order to support the interpretation of the serological test results; in particular where in officially brucellosis-free or brucellosis-free bovine herds a cross-reaction with antibodies against other bacteria cannot be excluded.
Govedo, ki je bilo v enem od seroloških testov iz te priloge pozitivno, se lahko testira z BST za podporo razlagi rezultatov seroloških testov; zlasti če se pri čredah, ki so proste ali uradno proste bruceloze, ne more izključiti navzkrižna reakcija s protitelesi proti drugim bakterijam.
The test must be carried out by use of a standardised and defined brucellosis allergen preparation that does not contain smooth lipopolysaccharide (LPS) antigen, as this may provoke non-specific inflammatory reactions or interfere with subsequent serological tests.
Test je treba opraviti z uporabo standardiziranega in definiranega preparata brucelnega alergena, ki ne vsebuje gladkega lipopolisaharidnega (LPS) antigena, ki lahko povzroči nespecifične vnetne reakcije ali moti naknadne serološke teste.
The requirements for the production of brucellin shall comply with Section C1 of Chapter 2.4.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.
Zahteve za izdelavo brucelina so natančneje opisane v oddelku C1 poglavja 2.4.3 Priročnika za diagnostične teste in cepiva za kopenske živali OIE, šesta izdaja, 2008.
Test procedure
Postopek testa
A volume of 0.1 ml of brucellosis allergen shall be injected intradermally into the caudal fold, the skin of the flank, or the side of the neck.
0,1 ml brucelnega alergena se vbrizga intradermalno v obrepno gubo, kožo boka ali ob strani v vrat.
The test shall be read after 48- to 72-hours.
Test se odčita po 48–72 urah.
The skin thickness at the injection site shall be measured with vernier callipers before injection and at re-examination.
Debelina kože na mestu injekcije se izmeri s kutimetrom pred aplikacijo in pri ponovnem pregledu.
Strong reactions are easily recognised by local swelling and induration.
Močne reakcije se zlahka prepoznajo po lokalni oteklini in zatrdlini.
Skin thickening of 1 to 2 mm shall be considered as positive reaction to the BST.
Zadebelitev kože za 1,5 do 2 mm se pojmuje kot pozitivna reakcija na BST.
Competitive enzyme-linked immunosorbent assay (cELISA)
Kompetitivni encimskoimunski test (cELISA)
Conditions for the use of cELISA
Pogoji za uporabo cELISA testa
The cELISA shall not be used for the purpose of certification for intra-Community trade.
cELISA test za brucelozo se ne uporablja za namene certificiranja za trgovino znotraj Skupnosti.
Bovine animals, tested with positive result in one of the other serological tests defined in this Annex may be subject to a cELISA in order to support the interpretation of the other serological test results; in particular where in the officially brucellosis-free or brucellosis-free bovine herds a cross-reaction with antibodies against other bacteria cannot be excluded or to eliminate reactions due to residual antibodies produced in response to vaccination with S19.
Govedo, ki je bilo v enem drugem od seroloških testov iz te priloge pozitivno, se lahko testira s cELISA za podporo razlagi drugih rezultatov seroloških testov; zlasti kadar se pri čredah, ki so proste ali uradno proste bruceloze, ne more izključiti navzkrižne reakcije s protitelesi proti drugim bakterijam, ali da se preprečijo reakcije zaradi ostanka protiteles, nastalih zaradi cepljenja s S19.
The test shall be carried out in accordance with the prescription in Section B(2) of Chapter 2.4.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.’
Test se izvede v skladu z navodili iz oddelka B(2) poglavja 2.4.3 Priročnika za diagnostične teste in cepiva za kopenske živali OIE, šesta izdaja, 2008.“
For the purpose of this Annex, dilutions given for making up liquid reagents are expressed as, for example, 1/150 shall mean a 1 in 150 dilution.
Za namen te priloge so razredčine za tekoče reagente izražene tako, da na primer 1/150 pomeni razredčino 1:150.
In Annex C to Directive 64/432/EEC point 4.1 is replaced by the following:
Točka 4.1 Priloge C k Direktivi 64/432/EGS se nadomesti z naslednjim:
Tasks and responsibilities
Naloge in pristojnosti
National reference laboratories designated in accordance with Article 6a shall be responsible for:
Nacionalni referenčni laboratoriji so odgovorni za:
the approval of the results of the validation studies demonstrating the reliability of the test method used in the Member State;
odobritev rezultatov ocenjevalnih študij za dokaz zanesljivosti metode za testiranje, ki se uporablja v državi članici;
determination of the maximum number of samples to be pooled in ELISA kits used;
določitev maksimalnega števila vzorcev, ki se jih lahko pri uporabljanih ELISA kitih združi v skupinski vzorec;
calibration of working standards as referred to in point 2.1.6;
kalibracijo delovnih standardov iz točke 2.1.6;
quality checks of all antigens and ELISA kits batches used in the Member State;
kontrolo kvalitete vseh serij antigenov in ELISA kitov, ki se uporabljajo v državi članici;
following recommendations of, and cooperating with the Community reference laboratory for brucellosis.’
upoštevanje priporočil Referenčnega laboratorija Skupnosti za brucelozo in sodelovanje z njim.“
authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
o odobritvi dajanja na trg listov Morinda citrifolia kot nove živilske sestavine v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta
(notified under document number C(2008) 8108)
(notificirano pod dokumentarno številko C(2008) 8108)
On 10 November 2004 Baker & McKenzie on behalf of Morinda Inc., made a request to the competent authorities of Belgium to place the leaves of Morinda citrifolia on the market as a novel food ingredient.
Podjetje Baker & McKenzie je 10. novembra 2004 v imenu podjetja Morinda Inc. pri pristojnih organih Belgije vložilo zahtevek za dajanje na trg listov Morinda citrifolia kot nove živilske sestavine.
On 30 November 2005 the competent food assessment body of Belgium issued its initial assessment report.
Pristojni organ Belgije za ocenjevanje živil je 30. novembra 2005 izdal poročilo o začetni oceni.
In that report it came to the conclusion that an additional assessment was required.
V navedenem poročilu je prišel do ugotovitve, da je potrebna dodatna ocena.
The Commission forwarded the initial assessment report to all Member States on 21 March 2006.
Komisija je 21. marca 2006 poslala poročilo o začetni oceni vsem državam članicam.
Some Member States raised additional questions about the safety of the leaves of Morinda citrifolia.
Nekatere države članice so postavile dodatna vprašanja o varnosti listov Morinda citrifolia.
Therefore the European Food Safety Authority (EFSA) was consulted on 14 November 2006.
Zato je bil 14. novembra 2006 opravljen posvet z Evropsko agencijo za varnost hrane (EFSA).
On 10 July 2008 EFSA adopted the ‘Opinion of the Scientific Panel on dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of leaves from Morinda citrifolia L.’.
EFSA je 10. julija 2008 sprejela „Mnenje znanstvenega sveta za dietetične izdelke, prehrano in alergije na zahtevo Komisije v zvezi z varnostjo listov Morinda citrifolia L.“.
In the opinion the panel came to the conclusion that the use of dried and roasted M. citrifolia leaves for the preparation of infusions at the anticipated levels of intake is safe.
V mnenju svet navaja ugotovitev, da je uporaba posušenih in praženih listov Morinda citrifolia za pripravo poparkov pri predvidenih vrednostih vnosa varna.
On the basis of the scientific assessment, it is established that dried and roasted leaves of Morinda citrifolia comply with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
Iz znanstvene ocene izhaja, da posušeni in praženi listi Morinda citrifolia izpolnjujejo merila iz člena 3(1) Uredbe (ES) št. 258/97.
Dried and roasted leaves of Morinda citrifolia as specified in the Annex may be placed on the market in the Community as a novel food ingredient for the preparation of infusions.
Posušeni in praženi listi Morinda citrifolia, kakor so opredeljeni v Prilogi, se lahko dajejo na trg Skupnosti kot nova živilska sestavina za pripravo poparkov.
The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Noni leaves’ or ‘leaves of Morinda citrifolia’.
Nova živilska sestavina, odobrena s to odločbo o označevanju živil, ki jo vsebujejo, se poimenuje „listi nonija“ ali „listi Morinda citrifolia“.
Dried and roasted leaves of Morinda citrifolia shall be exclusively used for the preparation of infusions.
Posušeni in praženi listi Morinda citrifolia se uporabljajo izključno za pripravo poparkov.
They shall be presented in such a manner that a cup of infusion to be consumed would not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.
Ti listi se pripravijo tako, da skodelica poparka za uživanje ne vsebuje več kot 1 g posušenih in praženih listov Morinda citrifolia.
This Decision is addressed to Morinda Inc., 333 West River Park Drive, Provo, Utah 84604, USA
Ta odločba je naslovljena na podjetje Morinda Inc., 333 West River Park Drive, Provo, Utah 84604, ZDA
SPECIFICATIONS OF DRIED AND ROASTED LEAVES OF MORINDA CITRIFOLIA
ZAHTEVE ZA POSUŠENE IN PRAŽENE LISTE MORINDA CITRIFOLIA
After cutting, the leaves of Morinda citrifolia are subject to drying and roasting steps.
Listi Morinda citrifolia se po trganju sušijo in pražijo v več korakih.
The product has a particle size ranging from broken leaves to coarse powder with fines.
Proizvod je v obliki delcev, vsebuje pa zlomljene liste in grob prah z drobnimi delci.
It is of greenish brown to brown colour.
Je zelenorjave do rjave barve.
Composition of dried and roasted leaves of M. citrifolia
Sestava posušenih in praženih listov M. citrifolia
Carbohydrate
Ogljikovi hidrati
Ash
Pepel
less than 47 mg/kg
manj kot 47 mg/kg
non detectable
pod mejo zaznavnosti
5,15-dimethylmorindol
5,15-dimetilmorindol
concerning the non-inclusion of antraquinone in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance
o nevključitvi antrakinona v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov
(notified under document number C(2008) 8133)
(notificirano pod dokumentarno številko C(2008) 8133)
That list includes antraquinone.
Navedeni seznam vključuje antrakinon.
For antraquinone the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) No 2229/2004 for a range of uses proposed by the notifier.
Vplivi antrakinona na zdravje ljudi in okolje so bili ocenjeni v skladu z določbami uredb (ES) št. 1112/2002 in (ES) št. 2229/2004 za vrste uporab, ki jih je predlagal prijavitelj.
For antraquinone the rapporteur Member State was Belgium and all relevant information was submitted in September 2006.
Država članica poročevalka za antrakinon je bila Belgija, vse ustrezne informacije pa so bile predložene septembra 2006.
The Commission examined antraquinone in accordance with Article 24a of Regulation (EC) No 2229/2004.
Komisija je antrakinon preučila v skladu s členom 24a Uredbe (ES) št. 2229/2004.
A draft review report for that substance was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 26 September 2008 in the format of the Commission review report.
Osnutek poročila o pregledu za navedeno snov so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 26. septembra 2008 v obliki poročila Komisije o pregledu glede antrakinona.
During the examination of this active substance by the Committee, taking into account comments received from Member States, it was concluded that there are clear indications that it may be expected that it has harmful effects on human health and in particular the crucial missing data does not allow to set reliable acceptable daily intake (ADI), acute reference dose (ARfD) and acceptable operator exposure level (AOEL) and such values are necessary to conduct the risk assessment.
Med preučevanjem te aktivne snovi, ki ga je opravil Odbor ob upoštevanju pripomb držav članic, je bilo ugotovljeno, da obstajajo jasni znaki, da se lahko pričakuje, da ima škodljive učinke na zdravje ljudi, zlasti pa manjkajoči ključni podatki ne omogočajo določitve sprejemljivega dnevnega vnosa (ADI), akutnega referenčnega odmerka (ARfD) in dopustne izpostavljenosti delavca (AOEL), takšne vrednosti pa so potrebne za izvedbo ocene tveganja.
Moreover, other concerns which were identified by the rapporteur Member State in its assessment report are included in the review report for the substance.
Poleg tega so v poročilo o pregledu za snov vključeni tudi drugi pomisleki, ki jih je opredelila država članica poročevalka v svojem poročilu o oceni.
The Commission invited the notifier to submit its comments on the results of the examination of antraquinone and on its intention or not to further support the substance.
Komisija je prijavitelja pozvala, naj predloži pripombe o rezultatih pregleda antrakinona in sporoči, ali bo še naprej vztrajal pri vključitvi navedene snovi na seznam.
However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing antraquinone satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Toda kljub argumentom, ki jih je prijavitelj predložil, se navedenih pomislekov ni dalo odpraviti, po ocenah na podlagi predloženih informacij pa ne kaže pričakovati, da bi lahko fitofarmacevtska sredstva, ki vsebujejo antrakinon, pod predvidenimi pogoji uporabe na splošno izpolnjevala zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS.
Antraquinone should therefore not be included in Annex I to Directive 91/414/EEC.
Antrakinon se zato ne sme vključiti v Prilogo I k Direktivi 91/414/EGS.
Measures should be taken to ensure that authorisations granted for plant protection products containing antraquinone are withdrawn within a fixed period of time and are not renewed and that no new authorisations for such products are granted.
Sprejeti je treba ukrepe za zagotovitev, da se registracije fitofarmacevtskih sredstev, ki vsebujejo antrakinon, prekličejo v predpisanem roku in se ne podaljšajo ali izdajo nove registracije takih sredstev.