natgillin/translations-raw huggingface dataset:
Ved vurderingen af de toksikologiske data for dette karamelfarvestof var det klart, at nedgangen i antallet af cirkulerende lymfocytter hos rotter hovedsagelig, om ikke udelukkende, bestemmes af tilstedeværelsen af THI i produktet.
In the evaluation of the toxicological data on this caramel, it was clear that the reduction in circulating lymphocytes in the rat is mainly, if not only, determined by the presence of THI in the product.
Foruden tilstedeværelsen af dette stof i ammonieret karamel er en anden faktor, nemlig kostens indhold af pyridoxin (vitamin B,), medvirkende til at bestemme effekten.
Besides the presence of this substance in ammonia caramel colour, another factor, i.e. the content of pyridoxine (Vitamin Β) in the diet, modulates the effect.
Med høje doser vitamin B, hos rotter konstateres der ingen effekt; ved lave niveauer forekommer aer en formindskelse af antallet af lymfocytter.
With high doses of Vitamin B, in the rat, no effect is found; with low levels, a reduction of the number of lymphocytes occurs.
Det ville således være hensigtsmæssigt at vide, om der kunne fastlægges et nul-effektniveau for THI; med andre ord, om der kunne etableres og beregnes et kvantitativt forhold mellem faldet i det absolutte antal cirkulerende lymfocytter ved indgift af THI (da ammonieret karamel har et kendt THI-indhold) og kostens pyridoxin-indhold.
The question arose whether it would be possible to establish a no-effect level for THI; in other words, to establish and calculate a quantitative relationship between the degree of reduction of the absolute numbers of circulating lymphocytes by feeding THI (as ammonia caramel having known contents of ΤΉΙ) and the pyridoxine content of the diet.
Ved ekstrapolering af disse tal til mennesket er det et spørgsmål, om faldet i lymfocyttallet skal betragtes som en toksisk virkning, da genopretning finder sted.
In extrapolating these figures to man, there is a question whether the decrease in lymphocytes should be considered as a toxic effect since recovery takes place.
Hvis faldet betragtes som en toksisk virkning, må der tages hensyn til, at visse befolkningsgrupper mangler vitamin B. eller indtager en kost med et lavt vitamin Β,-indhold.
If the decrease is considered a toxic effect, then account must be taken that certain groups of the population are deficient in Vitamin B., or have a low vitamin B, in the diet.
Det vides faktisk ikke, om der ville være nogen som helst virkning for mennesket.
In fact, it is not known whether or not man would Be affected at all.
Pa grundlag af disse oplysninger og i betragtning af, at personer med et stort ølforbrug mi forventes at være den gruppe, der indtager mest
On the basis of this information and having in mind that heavy beer drinkers would be expected to be the group consuming the most ammonia caramel, the Committee concluded that THI should not be present at more than 10 mg/kg caramel (on a colour intensity basis) in caramel.
Komiséen kan dog midlertidigt acceptere et niveau på 25 mg THI/kg karamel af hensyn til industriens tilpasning, og den ville være villig til at tage situationen op til fornyet undersøgelse.
However, the Committee can temporarily accept a level of 25 mg of THI/kg of caramel to allow for industry to adapt, and would be willing to review the situation.
Der kan fastlægges et nul-effektniveau for lymphopeni-virkningen af ammonieret karamel med kendt THI-indhold.
A no-effect level for the lymphocytophenic effect of ammonia caramels of known THI content can be established.
Dette niveau afhænger af dyrefoderets indhold af vitamin B,.
This level depends on the vitamin B. content of the animal diet.
Ved beregningen valgtes en dosis pi 5 mg vitamin B,/kg dyrefoder, der af komitéen betragtes som svarende til en marginal vitamin B,-indtagelse hos mennesker.
An intake of 5 mg vitamin Β /kg animal diet, which is considered by the Committee to be equivalent to a marginal vitamin B, intake in humans, was chosen for the calculation.
Der anvendtes derefter en sikkerhedsfaktor pa 10 i betragtning af lymphopeniens forbigående karakter, og herved fremkommer der for ammonieret karamel med et THI-indhold pi 25 mg/kg en acceptabel indtagelse pi indtil 400 mg/kg legemsvægt.
A safety factor of 10 was then applied in view of the transient nature of the lymphocytopenia, and this approach yields an acceptable intake for ammonia caramel with a THI content of 25 mg/kg of up to 400 mg/kg bw.
Hvad andre toksikologiske virkninger angår, fandt komitéen ved en fornyet gennemgang af 90-dages undersøgelsen og mutageni ci tetstesten, at disse forsøg var tilstrækkelige.
With regard to other toxicological effects, the Committee's re-examination of the 90-day study and the mutagenicity test reassured it as to their adequacy.
Der anvendtes en konventionel sikkerhedsfaktor på 100 pi disse data, således at der fremkom en ADI på 0-200 mg/kg legemsvægt, men komitéen betragtede denne som midlertidig forud for den nævnte fornyede undersøgelse.
A conventional safety factor of 100 was applied to these data to give an ADI of 0-200 mg/kg bw, but the Committee considered this to be temporary pending the review mentioned above.
Denne undersøgelse bør finde sted om senest fem ir.
This review should be undertaken at the latest in five years.
Nye langtidsundersøgelser med ammoniumsulphitkaramel hos rotter og mus viste ingen betydningsfulde virkninger.
New long-term studies using ammonia sulphite caramel on rats and mice showed no significant effects.
Komitéen mener, at dette karamelfarvestof (fremstillet ved kontrolleret varmebehandling af kulhydrater med ammonium- og sulphitforbindelser) er toksikologisk acceptabelt, og den fastsatte en ADI pi 0-200 mg/kg legemsvægt.
The Committee considers that this caramel (prepared by the controlled heat treatment of carbohydrates with ammonium and sulphite containing compounds) is toxicologically acceptable and the Committee set an ADI of 0-200 mg/kg bw.
Komitéen blev underrettet om, at beta-caroten ved en ny proces kan fremstilles af en algeart, Dunaliella S., der ikke anvendes som menneskeføde, og hvorfra farvestoffet udtrækkes.
The Committee was informed that beta-carotene may be produced by a new process from a species of algae Dunaliella S. which is not used as human food, from which the colouring is extracted.
Da det drejer sig om et nyt kildemateriale og en ny proces, kan der opstå sikkerhedsproblemer.
Because this is a new source material and a new process, safety problems might arise.
Produktet kan bringes i handelen i forskellige former.
The product can be marketed in several forms.
Hvad krystallinsk beta-caroten angår, forudser komitéen ingen sundhedsrisici i forbindelse med brug af dette stof, forudsat at beta-carotenet er i overensstemmelse med specifikationen for syntetisk beta-caroten.
As regards crystalline beta-carotene, the Committee foresees no health hazards in using this material, provided the beta-carotene complies with the specification for synthetic beta-carotene.
Komitéen vil gerne underrettes om tilstedeværelsen af eventuelle urenheder hidrørende fra kildematerialet og fremstillingsprocessen.
The Committee would like to be informed of the presence of possible impurities arising from the source and the manufacturing process.
Farvestoffet kan også sælges i form af en vegetabilsk olieekstrakt med et lavere indhold af beta-caroten.
The colouring may also be sold as a vegetable oil extract with lower content of beta-carotene.
For så vidt angår produkter med lave beta-carotenkoncentrationer, bør der forelægges yderligere detaljerede oplysninger om deres sammensætning.
For the products containing low concentrations of beta-carotene, additional detailed information on their composition should be provided to confirm that the possibility of the presence of toxins and other biologically-active substances is excluded.
Ovennævnte oplysninger bør fremlægges, således at komitéen kan tage stilling til, hvilke behov der er for yderligere undersøgelse af disse produkters sikkerhed.
The further information referred to above should be provided to enable the Committee to decide on the need and extent of further testing of the safety of these products.
Til den tid vil komitéen bedre kunne vurdere sådanne produkters sikkerhed og ligeledes, om det faktisk er hensigtsmæssigt at betegne dem "beta-caroten", eller der bør anvendes en anden betegnelse, som afspejler ekstraktens lave indhold af beta-caroten.
At that time the Committee will be better able to decide on the safety of such products, and indeed whether they are adequately designated "beta-carotene" or an alternative designation which reflects the low content of beta-carotene in the extract.
Siden komitéens vurdering af canthaxanthin som levnedsmiddeltilsætningsstof havde Kommissionen modtaget en række anmodninger om fornyet bedømmelse af stoffets sikkerhed, da der foreli rapporter om dannelse af krystalaflejringer i den menneskelige nethinde ved anvendelse af stoffet som et peroralt indgivet hudpigmenteringsstof.
Since the Committee's evaluation of canthaxanthin as a food additive, a number of requests had been received by the Commission to review the safety of the substance because of reports of the production of crystalline deposits in the human retina through its use as an orally-administered skin pigmenting agent.
Den hertil anvendte dosis konstateredes at være noget lavere end den, der var lagt til grund for beregningen af den nuværende ADI.
The dose used for this effect was found to be well below that for calculating the existing ADI.
Der er ikke fastlagt et nøjagtigt nul-effektniveau for krystalaflejring, men 30 mg pr. person pr. dag synes at være et minimalt effektniveau.
A precise no-effect level for crystal deposition has not been established, but 30 mg per person per day appears to be a minimal effect level.
Der er visse beviser for, at tilstedeværelsen af nethindeaflejringer kan medføre en formindskelse af den normale mørkeadaptation og fremkalde elekt roret i nografiske forandringer.
There is some evidence that the presence of retinal deposits can cause a reduction in normal dark adaptation and produce electroretinographic changes.
Der er foretaget en fornyet vurdering af ADI for canthaxanthin pi baggrund af disse oplysninger.
The ADI for canthaxanthin has been re-evaluated to take account of these data.
Ikke alle tidligere anvendte dyredata var til rådighed for komitéen ved denne vurdering.
Not all the animal data used in the past were now available to the Committee.
Den uventede virkning, der nu erkendes hos mennesket, var faktisk ikke blevet grundigt undersøgt i de dyremodeller, der blev anvendt, da undersøgelserne gennemførtes på rotter i begyndelsen af 1960'erne.
Indeed the unexpected effect now recognized in man had not been thoroughly investigated in animal models used when the studies were conducted on rats in the early 1960s.
Komitéen fandt, at iagttagelsen hos mennesker krævede en nøje klarlæggelse.
The Committee felt that the observation in humans required thorough elucidation.
Komitéen mener ligesom Det Fælles FAO/WHO-Ekspertudvalg for Tilsætningsstoffer i Levnedsmidler, der har gennemført en sideløbende vurdering af stoffet, at det er hensigtsmæssigt at anvende en 10-dobbelt sikkerhedsfaktor pi mindsteeffektniveauet i disse humane undersøgelser, hvilket giver en grænse pi 3 mg canthaxanthin pr. person pr. dag, eller en ADI pi 0,05 mg/kg legemsvægt.
The Committee, in common with the FA0/WH0 Joint Expert Committee on Food Additives which has carried out a concurrent evaluation of the substance, believes that it is appropriate to apply a 10-fold safety factor to the minimal effect level in these human studies, giving a limit of 3 mg canthaxanthin per person per day, or an ADI of 0.05 mg/kg bw.
Pa grund af usikkerhedsmomenter i humanundersøgelserne fastsættes dette som en midlertidig ADI, indtil der foreligger yderligere data.
Because of uncertainties in the human studies, this is adopted as a temporary ADI pending receipt of further data.
De yderligere data, der er behov for, omfatter undersøgelser hos dyr af
Human studies are also required to :
2. definition af de funktionelle virkninger, nethindeaflejringer medfører;
2. define what functional effects are caused by the retinal deposits;
3. konstatering af krystaldannelsens og eventuelle funktionelle forandringers reversibilitet.
3. establish the reversibility of crystal formation and any functional changes.
Oplysninger om canthaxanthins farmakokinetik hos mennesket, især med hensyn til fordeling og vævsaflej ring, ville også være ønskelige.
Data on the pharmacokinetics of canthaxanthin in humans, especially with respect to distribution and tissue deposition, would also be desirable.
ADI skal dække stoffets anvendelse som tilsætningsstof i levnedsmidler og den mængde, der indtages gennem dets anvendelse som tilsætningsstof i dyrefoder.
The ADI is intended to cover its use as a food additive and the amount ingested through its use as an additive in animal feeds.
Fabrikanterne af stoffet har underrettet komitéen om, at de "perorale solbruningsprodukter" nu stort set er forsvundet fra markedet.
The manufacturers of the substance have informed the Committee that the "oral skin tanning" products have now largely disappeared from the market.
Canthaxanthin bruges også til terapeutiske formil under lægetilsyn.
Canthaxanthin is also used for therapeutic reasons under medical supervision.
Denne anvendelse kræver efter komitéens opfattelse en klinisk vurdering og falder uden for dens omride.
In the opinion of the Committee this use is a matter for clinical judgement and falls outside its remit.
Komitéen fik forelagt et materiale om et stof betegnet "crocin", som faktisk var en ekstrakt af en blanding af carotenoidpigmenter fra frugten af Gardenia jasminoides Ellis (fam. Rubiaceae). Crocin ^,,Η,.Ο-,) og
A submission was made to the Committee for the use of a material denominated as "crocin" which was in fact an extract of a mixture of carotenoid pigments from the fruit of Gardenia jasminoides Ellis (fam. Rubiaceae).
Crocetin ^2(,Hp,0 ) siges at være de to hovedbestanddele.
Crocin ^,,Η,,Ορ,) and Crocetin (C^Hp/O,) are said to be the two main components.
Øer kan også fremstilles et produkt af tørret safran ved ekstraktion og renfremstilling.
A product may also be prepared from dried saffron by extraction and purification.
Den, der fremlagde oplysningerne, henviste til flere ekstraktionsprocesser (vandproces, alkoholproces) i forskellige dele af materialet og de medfølgende toksikologiske data.
The sponsor of the data reported various extraction processes (aqueous, alcoholic) in different parts of the submission and the supporting toxicological data.
Komitéen kunne ikke give en vurdering af ekstrakterne på grundlag af de forelagte toksikologiske data.
The Committee was unable to give an evaluation of the extracts on the basis of the toxicological data submitted.
Det ser ud til, at pigmentet har en vis virkning på leveren, men dataene var vanskelige at fortolke.
It appears that the pigment has some effect on the liver but the data were difficult to interpret.
Identiteten af de stoffer, de vedrørte, fremgik ikke klart.
The identity of the materials to which they referred was not clear.
En vurdering af, om disse ekstrakter af safran eller gadeniafrugter er acceptable som levnedsmiddelfarvestoffer, vil kræve, at komitéen først får forelagt undersøgelser udført efter dens retningslinjer (rapporter, 10. serie) som følger:
Before these extracts of saffron or gardenia fruits could be assessed for their acceptability as food colours, the Committee would require the submission of studies carried out using the Committee's guidelines (10th Series of Reports) as follows :
1. passende afprøvning med et velspecificeret materiale;
as a priority a proper 90-day study including, especially, monitoring of hepatic function.
Der bør forelægges et skøn over den i levnedsmiddelindustrien påtænkte brug, herunder indtagelse af tilsvarende stof (safran) som kilde til smagsstoffer.
Estimates of usage envisaged by the food industry should be provided, including intake of similar material (saffron) as a source of flavourings.
Siden komitéen sidst vurderede erythrosin, er der blevet en betydelig mængde nye data til rådighed, herunder nye langtidsundersøgelser, undersøgelser af hormonale virkninger hos dyr og mennesker og nye mutagenicitetsundersøgelser.
Since erythrosine was last considered by the Committee a considerable amount of new data have become available including new long-term studies, animal and human studies on hormonal effects, and new mutagenicity studies.
Komitéen gennemgik disse data.
These were reviewed by the Committee.
Erythrosin har vist sig at forårsage en stigning i forekomsten af follikulære adenomer i skjoldbruskkirtlen hos hanrotter ved indgift i store doser under en langtidsundersøgelse omfattende to generationer.
Erythrosine has been shown to cause an increase in the incidence of thyroid follicular adenomas in male rats when fed at high doses in a 2-generation long-term study. There is also some equivocal evidence for an increased incidence of thyroid carcinoma.
Der er også visse usikre beviser for en øget forekomst af skjoldbruskkirtelkarcinomer.
In vitro studies have shown that erythrosine inhibits the conversion of T4 to T3 in the liver.
Undersøgelser hos dyr af erythrosins virkninger på skjoldbruskkirtel- og hypofysefunktionen viser generelt et konsistent billede.
These findings suggest a mechanism of action for the effects of erythrosine in producing thyroid hyperplasia.
Niveauet for serumhyroxin (T4) og skjoldbruskki rtelstimulerende hormon > .TSH) er forhøjet, mens niveauet for serumtri-iodothyronin (T3) er nedsat. In vitro undersøgelser har vist, at erythrosin hæmmer omdannelsen af T4 til T3 i leveren. Disse resultater tyder pi, at virkningerne af erythrosin bidrager til at fremkalde thyreo-hyperplasi. Hæmningen af omdannelsen af T4 til T3 vil medføre reducerede vævs- og plasmaniveauer for T3, hvilket igen vil nedsætte T3's hæmmende virkning pi TSH-sekretionen. Den deraf følgende forøgelse af TSH-sekretionen vil stimulere skjoldbruskkirtlen, hvilket kan medføre hypertrofi, adenomdannelse og muligvis ondartede forandringer. Tidligere mutagenicitetsdata, overvejende baseret pi bakterieforsøg, var stort set negative, selv om der var tegn pi, at stoffet kunne fremkalde genmutationer i gær, dog kun i mørke typer, og kromosomskader in vitro; for clastogenicitet gav 2/3 af in vivo undersøgelserne imidlertid negative resultater.
Earlier mutagenicity data based mainly on bacterial assays were largely negative, although there was an indication that the compound could produce gene mutation in yeasts, albeit only in the dark, and chromosome damage in vitro; negative results however were obtained in 2/3 in vivo assays for clastogeni city.
Der er fornylig opnået negative resultater i forsøg til undersøgelse af punktmutationer hos bakterier og genmutationer i dyrkede pattedyrsceller.
Recently negative results have been obtained in assays for point mutations in bacteria, and for gene mutation in cultured mammalian cells.
Negative resultater opnåedes også i undersøgelser af clastogene virkninger in vivo.
Negative results were also obtained in tests for clastogenic effects in vivo.
Der foreligger desuden negative resultater fra to undersøgelser vedrørende DNA-skader, nemlig en rekombination rekombinationsundersøgelse på gær og en UDS-undersøgelse på rotteleverceller in vitro.
In addition negative results were obtained in 2 tests indicative of DNA damage, namely a recombination assay in yeasts and an UDS assay in rat hepatocytes in vitro.
På baggrund af de nye data kan det nu konkluderes, at erythrosin ikke har mutagene virkninger hos pattedyr.
In the light of the new data it is now possible to conclude that erythrosine is not mutagenic in mammals.
I betragtning af ovennævnte resultater konkluderede komitéen, at de onkogene virkninger, der kunne konstateres i langtidsundersøgelserne, sandsynligvis var sekundærvirkninger af erythrosins virkninger på
In view of the above findings the Committee concluded that the oncogenic effects seen in the long-term studies were likely to be secondary to the effects of erythrosine on thyroid and pituitary function, and that an acceptable daily intake could be established based on the no-effect level for these hormonal effects.
Sidstnævnte dosis blev sat lig med 1 mg/kg legemsvægt/dag, og komitéen har fastsat en ADI ved anvendelse af en sikkerhedsfaktor på 10 for at tage hensyn til det lille antal individer, der indgik i undersøgelsen, og dennes ret korte varighed.
taken to be equivalent to 1 mg/kg bw/day, and the Committee has set an ADI using a safety factor of 10 to allow for the small number of subjects used in the study and its relatively short duration.
Komitéen konkluderede derfor, at anvendelsen af erythrosin var acceptabel under forudsætning af en ADI på 0-0,1 mg/kg legemsvægt.
The Committee has therefore concluded that the use of erythrosine was acceptable subject to an ADI of 0-0.1 mg/kg bw.
Komitéen godkendte allerede i 1975 (1) anvendelsen af lycopen fremstillet af levnedsmidler ad fysisk vej, selv om den ikke kunne fastsætte en ADI.
The Committee has already in 1975(1) accepted the use of lycopene obtained from foods by physical means although it had been unable to set an ADI.
Komitéen har ingen indsigelse mod den fortsatte brug af et sådant stof, men pipeger, at den tidligere i denne rapport har fremsat bemærkninger om brugen af naturlige produkter og den mulige udstrækning af denne brug
The Committee has no objection to the continued use of such a material but points out that it has already commented about the use of natural products and the possible extension of their use in the present report.
Hvis der skulle blive et syntetisk stof til rådighed, ville komitéen forvente at vurdere det pi grundlag af et moderne toksikologisk datamateriale som behørigt for stoffet og den påtænkte anvendelse af det.
If a synthetic substance would become available, the Committee would expect to evaluate it in terms of a modem toxicological data base appropriate to the substance and its intended use.
Komitéen blev anmodet om at udtale sig om sikkerhedsaspekterne i forbindelse med skift fra methylviolet til enten Brown HT eller erythrosin til mærkning af kød i handelen inden for Fællesskabet.
The Committee was requested to comment on the safety aspects of a change from Methyl Violet to either Brown HT or Erythrosine for the marking of meat in intra-Community-trade.
Komitéen har tidligere afgivet en udtalelse om mærkningen af fersk kød med methylviolet, hvori den foreslog, at en sådan anvendelse skulle tages op til fornyet overvejelse på grund af dette farvestofs potentielle sundhedsskadelige virkninger (2). Komitéen støtter derfor et skift bort fra dette farvestof.
The Committee has already expressed an opinion on the marking of fresh meat by Methyl Violet in which it suggested that such use be reconsidered because of the potential adverse effects on health due to this colouring matter
Brown HT findes acceptabelt som tilsætningsstof til levnedsmidler (3).
Brown HT is considered acceptable as a food additive .
Anvendelsen af erythrosin bør begrænses på grund af den betydelige nedsættelse af ADI.
The use of Erythrosine should be restricted, because of the considerable reduction in the ADI.
(1) Den Videnskabelige Komité for Levnedsmidlers Første Rapport.
(1) 1st Report of the Scientific Committee for Food.
(2) Rapporter fra Den Videnskabelige Komité for Levnedsmidler, 4. serie, 1977.
(2) 4th Series of Reports of the SCF, 1977.
(3) Rapporter fra den Videnskabelige Komité for Levnedsmidler, 14. serie, 1983.
(3) 14th Series of Reports of the SCF, 1983.
RAlE0RI_EROEM-VlP.EigK,ABELI£E_KQJIIE FOR LEVKEDSHIDLER OH SifiESIfiEEEl (udtalelse afgivet 11. december 1987 og 10. november 1988)
(opinion expressed 11 December 1987 and 10 November 1988)
Ajourføring af Komitéens vurdering af sikkerheden ved brug af visse sødestoffer.
To update the Committee's review on the safety in use of certain sweeteners.
Komitéen gennemgik sødestofferne i 1984, og dens udtalelse offentliggjordes soa Komitéens sekstende rapportserie (1).
The Committee reviewed sweeteners in 1984 and its opinion was published as the Sixteenth Series of Reports of the Committee .