natgillin/translations-raw huggingface dataset:
Det foreliggende direktiv om tilnærmelse af medlemsstaternes love vedrørende de antioxidanter, der er godkendte til anvendelse i levnedsmidler beregnet til mennesker (70/357/EØF af 13. juli I97O) (l) tager ikke hensyn til anvendelsen af calciumdinatriumEDTA på fællesmarkedsniveau.
The present Directive on the approximation of the laws of the Member States concerning the antioxidants authorised for use in foodstuffs intended for human consumption (70/357/EEC of I3/7/1970K1) does not provide for the use at Community level of calcium disodium EDTA.
Tiltrædelsestraktaten (2) og en ændring til direktivet (74/412/EØF af 1. august 1974)(3) giver indtil 31. december I977 medlemsstaterne lov til at bibeholde bestemmelser, der godkender anvendelsen af dette stof, i deres nationale love.
The Treaty of Accession (2) and a modification to the Directive (74/412/EEC) of 1/8/1974) (3) permit Member States, until 31 December 1977, to maintain the provisions of their national laws authorising the use of this substance.
Kommissionen er ved at overveje, hvorvidt den skulle foreslå Rådet at calciumdinatriumEDTA indføjes i direktivet, og har bedt om at høre den videnskabelige Komité for Levnedsmidlers mening.
The Commission is considering whether or not it should propose to the Council that calcium disodium EDTA should be included in the Directive and has asked the Scientific Committee for Food for its opinion.
FAO/WHO's forenede ekspertudvalg vedrørende tilsætningsstoffer til levnedsmidler (JECFA) vurderede et antal data ved dets 9·(4) og 17.(5) møde.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered a number of data at its 9th (4) and 17th (5) meetings.
JECFA regnede med at det niveau, der ikke fremkalder nogen toxikologisk virkning hos rotter, var 0,5% i kosten svarende til 25O mg/kg legemsvægt.
JECFA considered that the level causing no
JECFA beregnede, at den acceptable daglige indtag se (ADI) for mennesker var 0-2,5 mg/kg legemsvægt.
JECFA toxicological effect in the rat was 0.5$ in the diet equivalent to 250 mgAg bw. estimated that the acceptable dialy intake for man was 0—2.5 mgAg bw.
Komiteen undersøgte alle disse oplysninger og tog også senere korttidsundersøgelser i betragtning.
The Committee examined all of this information and also took into account subsequent short—term studies.
Det tilsluttede sig den af JECFA fastlagte ADI-værdi på 0 - 2,5 mg/kg legemsvægt.
It endorsed the ADI established by JECFA of 0—2.5 nig/kg bw.
Imidlertid påpeger Komiteen, at calciumdinatriumEDTA under visse omstændigheder anvendes i terapi til behandling af forgiftning med tunge metaller.
However, the Committee points out that in certain circumstances calcium disodium EDTA is used in human therapy for the treatment of heavy metal intoxication.
Komiteen har fået oplyst, at calciumdinatriumEDTA kun er ønsket anvendt i visse velspecificerede produkter med lavt forbrug.
The Committee was informed that calcium disodium EDTA had only been requested for use in certain well—specified products of low consumption.
Under disse omstændigheder følte Komiteen, at anvendelsen af dette produkt kunne accepteres, men fremhævede at opmærksomheden bør være rettet mod at sikre at ADI-værdien ikke overskrides, hvis der skulle dukke nye anvendelsesområder op. Komiteen ville ønske at nyvurdere calciumnatrium-EDTA, hvis anvendelsen af dette stof blev udvidet i væsentligt omfang.
In these circumstances, the Committee felt that the use of this product could be accepted, but stressed that attention should be paid to ensure that the ADI was not exceeded if new uses were to be envisaged.
Komiteen var fortsat betænkelig ved anvendelsen af tilsætningsstoffer i levnedsmidler beregnet for mineralelementer og bør ikke anvendes i sådanne levnedsmidler.
The Committee continued to be concerned about the usage of additives in foods intended for consumption by infants less than 2 years of age. Calcium disodium EDTA is an effective séquestrant of mineral elements and should not be used in such foods.
RAPPORT FRA DEN VIDENSKABELIGE KOMITE FOR LEVNEDSMIDLER OM FARVESTOFFER.
REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON COLOURING MATTERS AUTHORIZED FOR USE IN FOODSTUFFS INTENDED FOR HUMAN CONSUMPTION
(Udtalelse afgivet den 16. september 1977)
(Opinion expressed 16 September 1977)
Komiteen blev anmodet om at undersøge sikkerheden ved anvendelsen af visse farvestoffer, som ikke var medtaget i dens første rapport om farvestoffer, som må anvendes i levnedsmidler (juni 1975)i °gom a"t overveje senere oplysninger om farvestoffer, der var medtaget i den t i dli gere rapport.
The Committee was asked to review the safety in use of certain colouring matters not included in its first report on colouring matters authorized for use in foodstuffs intended for human consumption (June 1975) and to consider information presented subsequently on colouring matters included in the earlier report.
Farvestoffer, for hvilke der har kunnet fastsættes en ADI, og som derfor ud fra et toksikologisk synspunkt kan accepteres til anvendelse i levnedsmidler inden for følgende grænser:
Colours for which an ADI could be established and which are therefore toxicologically acceptable for use in food within these limits:
Citranaxanthin (i foder til fjerkræ) skal medregnes i ADI på 0 - 5 mg/kg legemsvægt for jS-caroten B -apo-8'-carotenal
ADI 0-0.4 mg/kg bw citranaxanthin (in feedingstuff for poultry) to be included in the ADI of 0-5 mgAg bw for/*—carotene J) —ap 0—8'—car ote nal
Efter udarbejdelsen af komiteens rapport af juni 1975 undersøgte Kommissionen, hvorvidt der forelå andre oplysninger, som gjorde det muligt for komiteen at modificere eller ændre sin udtalelse.
Following the issue of the Committee's Report of June 1975 Ί-he Commission made enquiries as to whether other information was available which would permit the Committee to modify or change its opinion.
Som resultat af disse undersøgelser besluttede Kommissionen, at komiteen skulle anmodes om en udtalelse vedrørende de farvestoffer, som ikke blev behandlet i 1975 rapporten, og senere oplysninger om farvestoffer, der var medtaget i rapporten.
As a result of these enquiries the Commission decided that the Committee should be asked for an opinion on the colours not considered in the 1975 Report, and information presented subsequently on colours which were included in that Report.
Komiteen fik oplysninger vedrørende disse farvestoffers specifikaiioner, anvendelse og toksikologiske egenskaber.
The Committee was provided with information on the specification, uses and toxicological properties of these colours.
Komiteen ønsker at understrege, at dens udtalelse, som ønsket af Kommissionen, vedrører en vurdering af sikkerheden ved anvendelsen af disse farvestoffer, og at visse af dens medlemmers forbehold vedrørende det hensigtsmæssige i anvendelsen af farvestoffer fortsat gør sig gældende (se pkt. 7 i rapporten fra juni 1975)· at) anvendelse som mærkefarve bør atter overvejes. l) Rapporter fra Den videnskabelige Komite for Levnedsmidler (Første serie) 31. december 1975 (88OI/729O).
The Committee wishes to reiterate that its opinion relates, as requested by the Commission, to the evaluation of the safety in use of these colours, and that the reservations of some of its members on the need to use colours continues to exist (see paragraph 7 of the Report of June 1975).
Ved afgivelsen af udtalelsen har komiteen benyttet den samme fremgangsmåde, som den anvendte i sin første rapport, hvor principperne for bedømmelsen er beskrevet (pkt. 6­ll)
In giving its opinion the Committee has maintained the approach used in its first Report in which its principles for assessment including specification are described (paragraphs 6-11).
De pågældende farvestoffer henhører under tre af de grupper, der anvendtes i den tidligere rapport:
The colours under discussion fall into three of the groupings used in the earlier report:
­ farvestoffer, for hvilke der har kunnet fastsættes en ADI, og som derfor ud fra et toksikologisk synspunkt kan accepteres til anvendelse i levnedsmidler inden for disse grænser;
— colours for which an ADI could be established and which are therefore toxicologically acceptable for use in food within these limits;
­ farvestoffer, for hvilke der ikke har kunnet fastsættes en ADI, og som ud fra et toksikologisk synspunkt ikke kan accepteres til anvendelse i levnedsmidler.
— colours for which an ADI could not be established and which are not toxicologically acceptable for use in food.
Komiteens overvejelser er anført i detaljer nedenfor.
The detailed considerations of the Committee are listed below:
Citranaxanthin i foder til fjerkræ (5', 6'­dihydro­5'­apo­l8'­nor­^­caroten­6­one)
Citranaxanthin in feedingstuff s for poultry (5', ó'-^ihydro^'-apo-18'— nor— β—caroten-6— one)
Der findes ikke noget klart bevis for dette carotenoidfarvestofs naturlige forekomst.
No clear evidence exists for the natural occurrence of this carotenoid colour.
De oplysninger om stofskifte, der foreligger, peger hen imod en omdannelse til vitamin A af størstedelen af den optagne citranaxanthin, mens den resterende del aflejres i forskelligt væv, herunder blomme i fugleæg.
The available metabolic information points to conversion into vitamin A of the greater part of absorbed citranaxanthin, the remainder being deposited in various tissues, including the egg yolk of birds.
Langtidsundersøgelserne af rotter, som for nylig er afsluttet (der anvendtes en fremgangsmåde indført for en tre­fire år siden), gav ingen modstridende resultater på nogen af de undersøgte niveauer, hvoraf det højeste var 96 mg/kg legemsvægt citranaxanthin.
The long-term study in rats which has recently been completed (using a protocol established some 3 or 4 years ago) revealed no adverse findings at all intake levels tested, the highest being 86 mgAg bodyweight citranaxanthin.
Resultaterne af den seks måneder lange undersøgelse af hunde og af formeringsundersøgelsen over tre generationer af rotter gav ikke bevis for skadelige virkninger på de undersøgte parametre, herunder parametrene for formering og taratogene virkninger.
The available 6 months dog study and three generation—reproduction study in rats showed no evidence of adverse effects on the parameters studied including reproduction and teratogenicity.
På grundlag af disse oplysninger fastsatte komiteen en ADI for mennesker på 0 ­ 04 mg/kg legemsvægt.
On the basis of these data the Committee established an ADI of 0-4D.4 mgAg bodyweight for man.
Under hensyn til stofskifteomdannelsen til vitamin A bør denne ADI medregnes i den ADI på 0 ­ 5 mg/kg legemsvægt for alle carotenoider med provitamin A­aktivitet, der er fastsat foTj ­caroten, β ­apo­8'­carotenal og methyl­ og ethylesterne af /3­apo­8'­carotensyre (se komiteens rapport af 25. juni 1975)«
In addition, in view of the metabolic transformation to vitamin A, this ADI should be included in the ADI of 0—5 mgAg bodyweight for all carotenoids with provitamin A activity established fοτ/β-carotene,/9—apo—8'—carotenal and the methyl and ethylesters of > *"—apo-8*—caroteno!c acid (see Committee Report of 25 June 1975).
I betragtning af ADI'en og de små mængder, der vil blive anvendt, kan komiteen ud fra et toksikologisk synspunkt acceptere, at dette farvestof tilsættes fjerkræfoder.
Taking into account the ADI and the small amounts that would be used, the Committee has no objection on toxicological grounds to the use of this colour as an additive to poultry feed.
Komiteen gør imidlertid opmærksom på, at man ikke kan bedømme den ernæringsmæssige kvalitet af hverken en kylling eller et æg på grundlag af farven.
However, the Committee draws attention to the fact that neither the nutritional quality of a chicken, nor that of an egg, can be judged on the basis of its colour.
Komiteen var opmærksom på, at carotenoider med provitamin A­aktivitet, der tilsættes levnedsmidler, kan bidrage til den samlede indtagelse fra alle kilder, og henstiller, at der på et senere tidspunkt foretages en mere indgående undersøgelse af den ernæringsmæssige betydning, som det kan have.
The Committee was aware that carotenoids with provitamin A activity introduced into foods may contribute to the total intake from all sources and recommends that these nutritional implications be considered in greater depth at a future date.
Komiteen er kun blevet anmodet om at overveje, hvad farvning af æggeblommer ved tilsætning af ditranaxanthin til fjerkræfoder indebærer for forbrugernes sikkerhed.
The Committee has not been asked to consider the implications of the practice of colouring egg yolks by adding citranaxanthin to poultry feed except in terms of safety to the consumer.
Den er klar over, at andre aspekter af dette spørgsmål for øjeblikket drøftes af Kommissionens tjenestegrene i samråd med medlemsstaternes regeringer samt af Den videnskabelige Komité for Foderstoffer.
It is aware that other aspects of this question are being discussed by the Commission Services in conjunction with the Member States Governments, and by the Scientific Committee for Animal Nutrition.
Komiteen udtalelse er allerede fremsendt til Den videnskabelige Komité for Foderstoffer.
The Opinion of the Committee has already been transmitted to the Scientific Committee for Animal Nutrition.
Komiteen fik forelagt oplysninger om riboflavin­5'­phosphat og data for riboflavin som supplement til de tidligere gennemgåede oplysninger.
The Committee was presented with information on riboflavin—5'—phosphate and additional data to that considered earlier in relation to riboflavin.
Da riboflavin.5'­phosphat er det normale stofskifteprodukt af riboflavin, har Komiteen ingen indvendiger imod, at dette stof anvendes til farvning af levnedsmidler, selv om der ikke foreligger fyldestgørende data for den toksikologiske virkning på dyr.
However, the Committee is of the opinion that, because of the photo—chemical instability of this substance, the problem of breakdown products requires investigation and that the use of this substance to colour food should not alter significantly the average daily intake of riboflavin.
Det er imidlertid komiteens opfattelse, at det på grund af dette stofs fotokemiske ustabilitet er nødvendigt at undersøge problemet med nedbrydningsprodukter, men at anvendelsen af dette stof til farvning af levnedsmidler ikke vil ændre den gennemsnitlige daglige indtagelse af riboflaving væsentligt. Komiteen
The Committee also recommends that riboflavin should be maintained in the list of permitted colouring matters, and not excluded from the scope of the Directive as was proposed in the Committee's first report on colouring matters.
Produktet, der påtænkes anvendt som farvestof i levnedsmidler, er et heksanekstrakt af blomsterbladene.
The product intended for use as a food colour is a hexane extract of the flower petals.
Produktet indeholder ca. 30% antheraxanthin i form af dipalmitat.
The product contains antheraxanthin at a level of about 30$ in the form of a dipalmitate.
Der forelå ingen toksikologiske oplysninger hverken om xantophyllerne eller om det kommercielle oleoharpiks, der påtænktes anvendt som farvestof i levnedsmidler.
No toxicological information was supplied either on the xanthophylls or on the commercial oleoresin intended to be used as a food colour.
Komiteen anbefaler derfor, at antheraxanthin oleoharpiks ikke anvendes til farvning af levnedsmidler.
The Committee recommends therefore, that antheraxanthin oleoresin should not be used to colour food.
Methylviolet er en blanding af hydrochloriderne af de mere denaturerede pararosaniliner, der hovedsagelig indeholder trtra­, pentan­ og hexamethylderivater.
Methyl violet is a mixture of the hydrochlorides of the more highly methylated pararosanilines containing principally tetra-, penta, and hexamethyl derivatives.
På grundlag af de meget få oplysninger, der forelå om akut toksicitet, og som ikke omfattede nogen resultater af prøver gennem munden, var komiteen ikke i stand til at vurdere dette farvestof.
On the basis of the very scanty acute toxicity data available which did not include any results of tests by the oral route the Committee could not evalute this colour.
Komiteen har forstået, at methylviolet kun tænkes anvendt som mærkefarve (f.eks. til kød, citrusfrugter).
The Committee understands that the only current use of methyl violet is as a marker (e.g. for meat, citrus fruit).
Komiteen henstiller, at dette farvestof ikke anvendes som farvestof i levnedsmidler, og at dets anvendelse som mærkefarve overvejes.
The Committee recommends that this substance should not be used to colour food and that its use as a marker should be reconsidered.
Dette azofarvestofs struktur er nært beslægtet med Red 2 G, som i syreopløsning langsomt hydrolyseres til Red 10 B. Fra et analytisk synspunkt kan der derfor i alle levnedsmidler, der indeholder Red 2G, være sport af Red 10 B. Betydelige mængder af dette hydrolyseprodukt kan sandsynligvis findes i produkter af stor surhedsgrad, der har været udsat for høje temperaturer under processen. Dette fænomen er ikke enestående for disse to farvestoffer.
The structure of this azodye is closely related to that of Red 2 G, which hydrolyses slowly in acid solution to give Red 10 B. From the analytical point of view therefore all food containing Red 2 G could contain traces of Red 10 B. Significant quantitites of this hydrolysis product are likely to be found in products of high acidity and subjected to high temperature during processing.
Red 10 Β har også været foreslået som et selvstændigt farvestof.
Red 10 Β has also been put forward as a colour in its own right.
Der foreligger kun få oplysninger om stofskifte i forbindelse med Red 10 B. Oplysninger vedrørende kort­ og langtidsundersøgelser af rotter og hunde samt vedrørende hudpenslingsundersøgelser forelå kun som en kortfattet rapport fra Food and Drug Administration, USA.
Only scanty metabolic information is available on Red 10 B. Information on short- and long—term tests in rats and dogs as well as skin painting studies was supplied only as a summary prepared by the U.S. Food and Drug Administration.
Disse undersøgelser viste, at Red 10 Β tilhører den klasse af blandingsstoffer, der fremkalder hæmolytisk anæmi og Heinz­legemer.
These studies showed that Red 10 Β belonged to the class of compounds causing haemolytic anaemia and Heinz body formation.
Resultaterne af langtidsundersøgelserne var ikke komplette og kunne ikke undersøges af komiteen, men selv ud fra de foreliggende rapporter forekom de utilstrækkelige med hensyn til antal anvendte dyr og tilrettelæggelse efter nutidig målestok.
The results of the long—term studies were not a available in full and could not be examined by the Committee, but even from the summaries available they appeared inadequate in terms of numbers of animals used and design, when judged by modern standards.
Der forelå ingen formeringsundersøgelser, men rapporten over de teratologiske undersøgelser syntes ikke at vise skadelige virkninger.
No reproduction studies were available but the summary of the teratology studies appeared to show no adverse effects.
På grundlag af de foreliggende oplysninger kunne komiteen ikke anbefale at Red 10 Β anvendes til farvning af levnedsmidler, Endvidere bør Red 2 G ikke anvendes under forhold, hvor der forekommer hydrolyse af Red 10 B i større omfang.
On the basis of the data available to it, the Committee was unable to recommend that Red 10 Β be used to colour food. In addition Red 2 G should not be used under conditions in which significant hydrolysis to Red 10 Β occurs.
Der forelå ingen oplysninger om dette farvestofs indvirkning på stofskiftet.
The Committee was unable to recommend that ultramarine be used to colour food.
Korttidsundersøgelsen af rotter fastslog et niveau uden skadelige virkninger, men der forelå ingen andre oplysninger om dyr.
The available data on this colour show that there is no adequate specification and that although some long—term studies appear to have been carried out in mice and rats most of the results were not available for evaluation and their adequacy could not be estimatedi
Komiteen kunne ikke anbefale, at ultramarin anvendes til farvning af levnedsmidler.
The Committee recommends that Violet BNP should not be used to colour food.
Da komiteen sidst vurderede dette farvestof (juni 1975), havde den fået oplyst, at det hovedsagelig anvendtes til farvning af sukkervarer.
At the time of its earlier assessment of this colouring matter (June 1975), "the Committee had been informed that the principal use was to colour sugar confectionary.
Ud fra de nu foreliggende oplysninger om andre anvendelsesmuligheder og om specifikation har komiteen kunne anbefale, at det optages i direktivet til anvendelse til levnedsmidler i almindelighed.
In the light of the new information presented to it on other potential uses and on specification the Committee felt able to recommend its inclusion in the Directive for food use in general.
Komiteen har nu fået oplyst, at det eneste produkt, der stemte overens med dets tidligere henstillinger med hensyn til grænserne for polycokliske aromatiske carbonhydrider, faktisk var E153.
The Committee hae been now informed that the only product which complied with its earlier recommendations on limits for polycyclic aromatic hydrocarbons was in fact E153.
Komiteen har også fået oplyst, at dette farvestof er blevet anvendt til at give mange levnedsmidler den rette nuance.
The Committee has also been informed that there was an application of this colouring matter in giving the necessary tint to the colour of several foodstuffs.
Det er ikke store mængder, der anvendes.
The quantities used are not large.
I betragtning af, at det er et traditionelt terapeutisk middel, har komiteen derfor kunnet anbefale, at dette stof bibeholdes i direktivet til anvendelse til levnedsmidler i almindelighed, selv om der ikke foreligger fyldestgørende data for den toksikologiske virkning på dyr.
In view of its use as a traditional therapeutic agent the Committee was therefore able to recommend the maintenance of the substance in the Directive for food use in general, despite the absence of extensive animal toxicological data.
RAPPORT FRA DEN VIDENSKABELIGE KOMITE FOR LEVNEDSMIDLER OM FORMALDEHYD I "GRANA PADANO " OST
REPORT OF THE SCIENTIFIC COMMITTEE FOR FOOD ON FORMALDEHYDE IN "GRANA PADANO" CHEESE
(Udtalelse afgivet den 20. oktober 1977)
(Opinion expressed 20 October 1977)
Afgive mening, om det på fællesskabsbasis af hensyn til forbrugernes helbred kunne accepteres, at der bruges formaldehyd under fremstillingen af "Grana Padano" ost.
To give an opinion on the acceptability on a Community basis from the point of view of the health of the consumer, of the use of formaldehyde in the production of "Grana Padano" cheese.
Komiteen accepterer, at den bestemmelse i direktivet om konserveringsmidler, der på national basis tillader anvendelsen af formaldehyii "Grana Padano" ost på betingelse af, at der ikke kan eftervises nogen rest, når osten bringes i handelen, kan udvides til at gælde for hele fællesmarkedet.
The Committee accepts that the provision in the Directive on Preservatives that permits, on a national basis, the use of formaldehyde in "Grana Padano" cheese provided that no residue is detectable when the cheese is marketed, may be extended to the whole Community.
BAGGRRUND
BACKGROUND
Det rådsdirektiv som vedrører en niende ændring af den indbyrdes tilnærmelse af medlemsstaternes love angående de konserveringsmidler, der tillades til anvendelse i levnedsmidler beregnet til mennesker (74/62/EØF af I7. december 1973) tillader medlemsstaterne at bibeholde de bestemmelser i deres nationale love, der vedrører anvendelsen af formaldehyd i"Grana Padano" ost, på den betingelse, at der, når produktet markedsføres, ikke kan eftervises nogen rest af formaldehyd i det færdige produkt (2).
The Council Directive making a ninth amendment to the approximation of the laws of the Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption (74/62/EEC of 17 December 1973)(l) permits Member States to maintain the provisions of their national laws relating to the use of formaldehyde in "Grana Padano" cheese provided that, when the product is marketed, no residue of formaldehyde is detectable in the finished product (2).