natgillin/translations-raw huggingface dataset:
For reviderede sikkerhedsdatablade angives det tydeligt, hvilke oplysninger der er tilføjet, slettet eller revideret (medmindre dette er angivet andetsteds).
For a revised safety data sheet, indicate clearly the information, which has been added, deleted or revised (unless this has been indicated elsewhere).
KEMISKE SIKKERHEDSVURDERINGER FOR PRÆPARATER
CHEMICAL SAFETY ASSESSMENTS FOR PREPARATIONS
For præparater skal den kemiske sikkerhedsvurdering udføres i overensstemmelse med bilag I, med følgende modifikationer:
A chemical safety assessment for a preparation shall be conducted in accordance with Annex I with the following modifications:
Den kemiske sikkerhedsvurdering skal bygge på oplysninger om de enkelte stoffer i præparatet som angivet i den tekniske dokumentation og/eller oplysninger givet af leverandøren i sikkerhedsdatabladet.
The chemical safety assessment for a preparation shall be based on the information on the individual substances in the preparation contained in the technical dossier and/or the information communicated by the supplier in the safety data sheet.
Den skal desuden bygge på de foreliggende oplysninger om selve præparatet.
It shall also be based on the information available on the preparation itself.
Risikovurderinger (menneskers sundhed, menneskers sundhed hvad angår fysisk-kemiske egenskaber samt miljø) udføres i overensstemmelse med punkt 1, 2 og 3 med følgende ændringer:
The hazard assessments (human health, human health for physicochemical properties and environmental) shall be carried out in accordance with Sections 1, 2 and 3 with the following alterations:
Med henblik på dataevalueringstrinnet (-trinnene) forelægges alle relevante data vedrørende præparatet, klassificeringen af hvert stof i præparatet og eventuelle særlige koncentrationsgrænser for hvert stof i præparatet.
For the evaluation of data step(s), any relevant data for the preparation, the classification for each substance in the preparation and any specific concentration limits for each substance in the preparation shall be presented.
Med henblik på klassificerings- og mærkningstrinnene skal præparatets klassificering og mærkning i henhold
For the classification and labelling step, the classification and labelling for the preparation in accordance
til direktiv
with Directive
1999/45/EF forelægges og begrundes.
1999/45/EC shall be presented and justified.
Til beregning af afledt nuleffektniveau (Dnel), angives Dnel-værdien for hvert stof i præparatet med behørig henvisning til leverandørens sikkerhedsdatablad, samt den beregnede Dnel-værdi for præparatet, ledsaget af en begrundelse for beregningsmåden.
For the derivation of derived no-effect levels (Dnels), the Dnel for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the Dnel derived for the preparation, with a justification on their derivation.
Virkningerne forudsættes at være additive, medmindre der foreligger oplysninger om det modsatte.
In lack of any information to the contrary, then additivity of effects shall be assumed.
Dnel-værdierne for præparatet kan da beregnes for hver eksponeringsvej og hvert eksponeringsscenario som et vægtet gennemsnit af Dnel-værdierne for hvert stof i præparatet, idet hvert stof i præparatet vægtes med en brøkdel svarende til, hvor stor en andel eksponeringen for stoffet udgør af den samlede eksponering for alle stoffer i præparatet.
The Dnels for the preparation can then be calculated for each route of exposure and each exposure scenario as a weighted average of the Dnels for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.
Til beregning af forventet nuleffektniveau (Pnec), angives Pnec-værdien for hvert stof i præparatet med behørig henvisning til leverandørens sikkerhedsdatablad samt den beregnede Pnec-værdi for præparatet, ledsaget af en begrundelse for beregningsmåden.
For the derivation of the predicted no-effect concentrations (Pnecs), the Pnec for each substance in the preparation with an appropriate reference to the safety data sheet of the supplier shall be listed, as well as the Pnecs derived for the preparation, with a justification on their derivation.
Pnec-værdierne for præparatet kan da beregnes for hvert delmiljø og hvert eksponeringsscenario som et vægtet gennemsnit af Pnec-værdierne for hvert stof i præparatet, idet hvert stof i præparatet vægtes med en brøkdel svarende til, hvor stor en andel eksponeringen for stoffet udgør af den samlede eksponering for alle stoffer i præparatet.
The Pnecs for the preparation can then be calculated for each environmental sphere and each exposure scenario as a weighted average of the Pnecs for each substance in the preparation, with the weights being the fraction of the exposure to the substance in the preparation to the total exposure to all substances in the preparation.
Indeholder præparatet et stof, der opfylder kriterierne i bilag XII, skal dette angives i den kemiske sikkerhedsrapport.
If the preparation contains a substance fulfilling the criteria given in Annex XII, then this shall be stated in the chemical safety report.
Formålet med eksponeringsvurderingen er at foretage en kvantitativ eller kvalitativ vurdering af den dosis/koncentration af præparatet, som mennesker og miljø bliver eller kan blive eksponeret for.
The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of the preparation to which humans and the environment are or may be exposed.
Eksponeringsscenarier skal opstilles i henhold til punkt 5.1 i bilag I. Eksponeringen beregnes for hvert af de opstillede eksponeringsscenarier og for hvert stof i præparatet i overensstemmelse med punkt 5.2 i bilag I.
Exposure scenarios shall be developed in accordance with Section 5.1 of Annex I. Exposure shall be estimated for each exposure scenario developed and for each substance in the preparation in accordance with Section 5.2 of Annex I.
Når virkningerne forudsættes additive, beregnes eksponeringsniveauet for præparatet for hver human eksponeringsvej og hvert delmiljø som summen af de beregnede værdier af eksponeringen for hvert stof i præparatet.
Assuming additivity of effects, then for each route of human exposure and each human population and for each environmental sphere, the estimation of the exposure level to the preparation is the sum of the estimates of the exposure level to each substance in the preparation.
BILAG IC
ANNEX IC
Det i artikel 11, litra a), omhandlede tekniske dossier skal omfatte alle de i bilag V specificerede oplysninger, såfremt registranten finder enten
The technical dossier referred to in Article 11(a) shall include the full information specified in Annex V where the registrant considers that either:
at der på grundlag af foreliggende data eller på grundlag af foreliggende og gyldige (Q)SAR'er ((quantitative) structure activity relationships) er tegn på, at stoffet kunne opfylde
there is an indication on the basis of available data or on the basis of available and valid (quantitative) structure – activity relationship (Q)SARs) that the substance may meet:
kriterierne for klassificering som kræftfremkaldende, mutagent eller reproduktionstoksisk eller
the criteria for classification as carcinogenic, mutagenic or toxic for reproduction; or
kriterierne i bilag XII (PBT, vPvB), eller
the criteria in Annex XII (PBT, vPvB); or
at stoffet, på grundlag af foreliggende oplysninger, sandsynligvis opfylder kriterierne for klassificering som farlige for menneskers sundhed eller miljøet og
the substance is likely to fulfil the criteria for classification on the basis of available information as dangerous with regard to human health or the environment and
anvendes alene eller i præparater beregnet til forbrugeranvendelse eller erhvervsmæssig anvendelse, eller
the substance is used as such or in preparations intended for consumer use or professional use; or
er inkorporeret i en artikel beregnet til forbrugeranvendelse og er beregnet til at blive frigivet fra en artikel under normale eller forudsigelige anvendelsesbetingelser.
the substance is incorporated into an article intended for consumer use and is intended to be released from an article during normal or foreseeable use conditions of use.
UNDTAGELSER FRA REGISTRERINGSPLIGTEN EFTER
EXEMPTIONS FROM OBLIGATION TO REGISTER IN ACCORDANCE WITH
ARTIKEL 4, STK.
ARTICLE 4 (1)
palmitinsyre, kemisk ren
Palmitic acid, pure
stearinsyre, kemisk ren
Stearic acid, pure
metan CH
Methane CH
oliesyre, kemisk ren
Oleic acid, pure
glycerolstearat, kemisk rent
Glycerol stearate, pure
laurinsyre, kemisk ren
Lauric acid, pure
natriumstearat, kemisk rent
Sodium stearate, pure
Et ikke-brændbart fast stof, karakteristisk for sedimentbjergarter.
A noncombustible solid characteristic of sedimentary rock.
Består primært af calciumcarbonat
It consists primarily of calcium carbonate
calciumdistearat, kemisk rent
Calcium distearate, pure
krypton Kr
Krypton Kr
neon Ne
Neon Ne
argon Ar
Argon Ar
carbon C
Carbon C
helium He
Helium He
xenon Xe
Xenon Xe
nitrogen N2
Nitrogen N2
vand, destilleret eller andet vand eller tilsvarende eller højere renhed
Water, distilled, conductivity or of similar purity
grafit C
Graphite C
ilt O
Oxygen O
Ekstrakter og deres fysisk modificerede derivater.
Extractives and their physically modified derivatives.
De består primært af glycerider af fedtsyrerne linolsyre, palmitinsyre og stearinsyre (Soja hispida, Leguminosae).
It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic and stearic (Soja hispida, Leguminosae).
De består primært af glycerider af fedtsyren linolsyre (Carthamus tinctorius, Compositae).
It consists primarily of the glycerides of the fatty acid linoleic (Carthamus tinctorius, Compositae).
De består primært af glycerider af fedtsyrerne linolsyre, linolensyre og oliesyre (Linum usitatissimum, Linaceae).
It consists primarily of the glycerides of the fatty acids linoleic, linolenic and oleic (Linum usitatissimum, Linaceae).
Ekstrakter og deres fysisk modificerede derivater
Extractives and their physically modified derivatives.
De består primært af glycerider af fedtsyren ricinusoliesyre (Ricinus communis, Euphorbiaceae).
It consists primarily of the glycerides of the fatty acid ricinoleic (Ricinus communis, Euphorbiaceae).
De består primært af glycerider af fedtsyrerne erucasyre, linolsyre og oliesyre (Brassica napus, Cruciferae).
It consists primarily of the glycerides of the fatty acids erucic, linoleic and oleic (Brassica napus, Cruciferae).
Den sammensatte blanding af diglycerider af fedtsyrer bundet til cholinesteren af phosphorsyre.
The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid.
sirupper, hydrolyserede stivelses-
Syrups, hydrolyzed starch
En sammensat blanding opnået ved hydrolyse af majsstivelse ved indvirkning af syrer eller enzymer.
A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes.
Den består primært af D-glucose, maltose og maltodextriner.
It consists primarily of d-glucose, maltose and maltodextrins.
Højpolymert kulhydrat, sædvanligvis udvundet fra kornkerner, såsom majs, hvede og durra og fra rødder og knolde, såsom kartofler og tapioka.
High-polymeric carbohydrate material usually derived form cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca.
Indbefatter stivelse, der er prægelatineret ved opvarmning i tilstedeværelse af vand.
Includes starch which has been pregelatinised by heating in the presence of water.
Denne forbindelse identificeres ved SDA Substance Name: C12-C18 alkyl carboxylic acid og SDA Reporting Number: 16-005-00.
This substance is identified by SDA Substance Name: C12-C18 alkyl carboxylic acid and SDA Reporting Number: 16-005-00.
Denne forbindelse identificeres ved SDA Substance Name: C16-C18 alkyl carboxylic acid og SDA Reporting Number: 19-005-00.
This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid and SDA Reporting Number: 19-005-00.
fedtsyrer, C8-18- og C18-umættede
Fatty acids, C8-18 and C18-unsatd.
Denne forbindelse identificeres ved SDA Substance Name: C8-C18 and C18 unsaturated alkyl carboxylic acid og SDA Reporting Number: 01-005-00.
This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 01-005-00.
fedtsyrer, C14-18- og C16-18-umættede
Fatty acids, C14-18 and C16-18-unsatd.
Denne forbindelse identificeres ved SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid og SDA Reporting Number: 04-005-00
This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 04-005-00
fedtsyrer, C16-C18- og C18-umættede
Fatty acids, C16-C18 and C18-unsatd.
Denne forbindelse identificeres ved SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid og SDA Reporting Number: 11-005-00
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 11-005-00
glycerider, C16-18 -og C18-umættede
Glycerides, C16-18 and C18-unsatd.
Denne forbindelse identificeres ved SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride og SDA Reporting Number: 11-001-00.
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00.
fedtsyrer C14-18- og C16-18-umættede, methylestere
Fatty acids, C14-18 and C16-18-unsatd., Me esters
Denne forbindelse identificeres ved SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester og SDA Reporting Number: 04-010-00.
This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid methyl ester and SDA Reporting Number: 04-010-00.
Denne forbindelse identificeres ved SDA Substance Name: C6-C12 alkyl carboxylic acid og SDA Reporting Number: 13-005-00.
This substance is identified by SDA Substance Name: C6-C12 alkyl carboxylic acid and SDA Reporting Number: 13-005-00.
fedtsyrer, C14-22- og C16-22 umættede
Fatty acids, C14-22 and C16-22 unsatd.
Denne forbindelse identificeres ved SDA Substance Name: C14-C22 and C16-C22 unsaturated alkyl carboxylic acid og SDA Reporting Number: 07-005-00
This substance is identified by SDA Substance Name: C14-C22 and C16-C22 unsaturated alkyl carboxylic acid and SDA Reporting Number: 07-005-00
glycerider, talg-, mono-, di- og tri-, hydrogenerede
Glycerides, tallow mono- , di- and tri-, hydrogenated
glycerider, C16-18- og C18-umættede mono- og di-
Glycerides, C16-18 and C18-unsatd. mono- and di-
Denne forbindelse identificeres ved SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride og SDA Reporting Number: 11-002-00.
This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00.
fedtsyrer, C12-18- og C18-umættede
Fatty acids, C12-18 and C18-unsatd.
hærdet, interesterificeret og fraktioneret sojaolie
Hydrogenated, interesterified and fractionated soybean oil
hærdet, interesterificeret og fraktioneret rapsfrøolie
Hydrogenated, interesterified and fractionated rapeseed oil
hærdet, interesterificeret og fraktioneret solsikkeolie
Hydrogenated, interesterified and fractionated sunflower oil
hærdet, interesterificeret og fraktioneret palmeolie
Hydrogenated, interesterified and fractionated palm oil
hærdet, interesterificeret og fraktioneret kokosolie
Hydrogenated, interesterified and fractionated coconut oil
hærdet, interesterificeret og fraktioneret palmekerneolie
Hydrogenated, interesterified and fractionated palmkernel oil
sojabønner, -bælge og -mel
Soybeans, hulls and meals
rRapsfrø, -bælge og -mel
Rapeseed, hulls and meals
Ekstrakter og deres fysisk modificerede derivater
Extractives and their physically modified derivatives
solsikkefrø, -skaller og -mel
Sunflower seeds, hulls and meals
ikke-oxyd glas
Non-oxide glass
fedtsyrer, rapsolie-, med lavt indhold af erucasyre
Fatty acids, rape-oil, erucic acid-low
inaktive gasser
Noble gases
Stoffer som citronsyre, sukker, olier, fedtsyrer etc., der normalt indgår i fødevarer
Substances commonly found in foodstuffs, such as citric acid, sugar, oils, fatty acids, etc.
Tekniske gasser som hydrogen, methan, oxygen, biogas
Industrial gases such as hydrogen, methane, oxygen and biogas
Uorganiske stoffer med stor udbredelse eller tilstrækkeligt kendskab til risiciene ved disse stoffer, f.eks. natriumchlorid, soda, potaske, calciumoxid, guld, sølv, aluminium, magnesium, silikater, glas, fritte.
Inorganic substances that are common, or the risks of which are well known, e.g. sodium chloride, soda, potash, calcium oxide, gold, silver, aluminium, magnesium, silicates, glass, frit
UNDTAGELSER FRA REGISTRERINGSPLIGTEN EFTER
EXEMPTIONS FROM THE OBLIGATION TO REGISTER
Stoffer, der er blevet radioaktive ved naturlig eller kunstig kerneomdannelse.
Substances rendered radioactive by either natural or artificial nuclear transformation;
Stoffer, der dannes ved en kemisk reaktion som følge af, at et andet stof eller en genstand udsættes for miljøfaktorer såsom luft, fugt, mikroorganismer eller sollys.
Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight;
Stoffer, der dannes ved en kemisk reaktion som følge af opbevaring af et andet stof, et præparat eller en genstand.
Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article;
Stoffer, som dannes ved en kemisk reaktion under slutanvendelse af andre stoffer, præparater eller genstande, og som ikke bliver fremstillet, importeret eller markedsført i sig selv.
Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market;
Stoffer, der dannes ved en kemisk reaktion:
Substances which result from a chemical reaction that occurs when:
når en stabilisator, et farvestof, et aromastof, en antioxidant, et fyldstof, et opløsningsmiddel, et bærestof, et tensid, en blødgører, et antikorrosionsmiddel, et antiskummiddel, et dispergeringsmiddel, en bundfaldshæmmer, et tørremiddel, et bindemiddel, en emulgator, et anti-emulgerende middel, et afvandingsmiddel, et agglomereringsmiddel, en vedhæftningsforbedrer, en flow modifier, et pH-neutraliserende middel, en kompleksbinder, et koaguleringsmiddel, et flokkuleringsmiddel, et brandhæmmende middel, et smøremiddel, et chelateringsmiddel eller et kvalitetsmodificerende reagens fungerer som tilsigtet, eller
a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or
Biprodukter, medmindre de bliver importeret eller markedsført i sig selv.
By-products, unless they are imported or placed on the market themselves;
Hydrater af et stof eller hydrerede ioner, der dannes ved binding af et stof til vand, forudsat at stoffet er registreret af en producent eller importør under påberåbelse af denne undtagelsesbestemmelse.
Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption;
Malme og koncentrater heraf, hvis de ikke modificeres kemisk under fremstillingen.
Ores and concentrates derived from them, if they are not chemically modified during their manufacturing;
flydende gas (LPG),
liquefied petroleum gas (LPG),
Mineraler, malme, koncentrater og andre materialer afledt heraf ved mineralogiske eller fysiske omdannelsesprocesser.
Minerals, ores and concentrates and other materials derived from them by mineralogical or physical transformation processes;
Procesgasser, såsom koksovnsgas, højovnsgas og motorgas fra olieraffinaderier, samt bestanddele heraf.
Process gases such as coke oven gas, blast furnace gas and fuel gas in oil refineries and components thereof.
OPLYSNINGSKRAV OMHANDLET I
INFORMATION REQUIREMENTS REFERRED TO IN
VEJLEDENDE BEMÆRKNINGER OM OPFYLDELSE AF KRAVENE I BILAG IV TIL IX
GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES IV TO IX
I bilag IV-IX specificeres det, hvilke oplysninger der skal forelægges med henblik på registrering og vurdering efter
Annexes IV to IX specify the information that shall be submitted for registration and evaluation purposes according to
artikel 11, 13 og 14, 45, 46 og 52
Articles 11, 13 and 14, 45, 46 and 52
For den laveste mængde gælder standardkravene i bilag V, og for hvert efterfølgende mængdeniveau udvides kravene som anført i det tilsvarende bilag.
For the lowest tonnage level, the standard requirements are in Annex V, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added.
De nøjagtige krav ved de enkelte registreringer er forskellige, alt efter mængde, anvendelse og eksponering.
For each registration the precise information requirements will differ, according to tonnage, use and exposure.
Bilagene skal således betragtes som en helhed og i sammenhæng med overordnede krav om registrering, vurdering og diligenspligt.
The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.
TRIN 1 -
STEP 1 – GATHER AND SHARE EXISTING INFORMATION
skal indsamle alle foreliggende testdata for det stof, der skal registreres.
should gather all existing available test data on the substance to be registered.
skal desuden indsamle alle andre foreliggende oplysninger om stoffet.
should also collect all other available information on the substance.
Disse bør omfatte alternative data (f.eks. fra (Q)SAR, analogisering fra andre stoffer, in vitro-undersøgelser, epidemiologiske data), som kan medvirke til at fastslå, om stoffet har farlige egenskaber eller ikke, og som i visse tilfælde kan erstatte resultaterne af dyreforsøg.
This should include alternative data (e.g. from (Q)SARs, read-across from other substances, in-vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.
Derudover indsamles der oplysninger om eksponering, anvendelse og risikostyringsforanstaltninger i henhold til
In addition, information on exposure, use and risk management measures in accordance with
kunne fastslå, om der er behov for at generere yderligere oplysninger.
will be able to determine the need to generate further information.
TRIN 2 - VURDERING AF BEHOVET FOR OPLYSNINGER
STEP 2 – CONSIDER INFORMATION NEEDS
Registranten skal fastlægge, hvilke oplysninger der er nødvendige til registreringen.
The registrant shall identify what information is required for the registration.
Først fastslås det, hvilket eller hvilke relevante bilag der skal overholdes i henhold til mængden.
First, the relevant Annex or Annexes to be followed shall be identified, according to tonnage.
I bilagene specificeres det, hvilke standardoplysninger der er obligatoriske, men der skal også tages højde for bilag IX, som giver mulighed for afvigelse fra standardmetoden, når det kan begrundes.
These Annexes set out the standard information requirements, but shall be considered in conjunction with Annex IX, which allows variation from the standard approach, where it can be justified.