natgillin/translations-raw huggingface dataset:
Det betyder i praksis, at 5-bromo-5-nitro-1,3-dioxan ikke må blandes med aminer og amider i kosmetiske produkter.
In practice this means that 5-bromo-5-nitro-1,3-dioxane must not be mixed with amines and amides in cosmetic products.
Desuden må stoffet kun bruges i kosmetiske produkter, som skal skylles af efter brug.
Furthermore, the substance is only permitted to be used in cosmetic products being cleansed after use.
Der mangler detaljerede oplysninger om 5-bromo-5-nitro-1,3-dioxan til at vurdere stoffets kritiske effekt, men der er ikke tvivl om, at kontaktallergi ved hudkontakt er en væsentlig effekt.
Detailed information about 5-bromo-5-nitro-1,3-dioxane is missing in order to assess the critical impact of the substance but there is no doubt that contact allergy at skin contact is a substantial impact.
7.2.1 Risikovurdering for benzylalkohol
7.2.1 Risk assessment for benzyl alcohol
Der er foretaget eksponeringsvurderinger af Kathon og benzylalkohol, da der for disse to stoffer foreligger en præcis bestemmelse af deres koncentration i analyserede produkter.
Exposure assessments on Kathon and benzyl alcohol are conducted as an exact determination of the concentration in the analyzed products is available for these two substances.
Der er ikke på samme måde foretaget kvantitative analyser for indholdsstofferne phenoxyethanol, natriumbenzoat eller 5-bromo-5-nitro-1,3-dioxan, hvorfor der ikke foretages en eksponeringsvurdering for disse stoffer.
Quantitative analyses of the constituents phenoxyethanol, sodium benzoate or 5-bromo-5-nitro-1,3-dioxane are not undertaken in the same way and therefore no exposure assessment will be conducted for these substances.
Retningslinjerne for eksponeringsvurderingen er givet i EU's Technical Guidance Document (TGD) (European Commission, 2003) og SCNNFP's guidelines (SCCNFP 0690, 2003).
The guidelines for the exposure assessment are stated in EU's Technical Guidance Document (TGD) (European Commission, 2003) and SCNNFP's guidelines (SCCNFP 0690, 2003).
Der er imidlertid ikke angivet en standardvægt for et barn i TGD.
However, no standard weight for a child is stated in the TGD.
Børns vægt for en bestemt alder kan findes via officielle vækstkurver.
Children's weight for a certain age can be found in official growth curves.
Netdoktor.dk har en tabel over piger og drenges vægt (se udpluk nedenfor), der stammer fra en ældre skandinavisk undersøgelse.
Netdoktor.dk has a table of girls' and boys' weight (see extract below) dating from an older Scandinavian study.
Tabel 7.1: Oversigt over skandinaviske børns vægt (Netdoktor, 2006).
Table 7.1: Overview of Scandinavian children's weight (Netdoktor, 2006).
Vægten fra 8 år og opefter skal tages med stort forbehold, da vægten varierer meget i puberteten.
The weight from 8 years and up must be taken with a reservation as the weight varies much in the puberty.
Målgruppen for dette projekt er børn i alderen 3-14 år.
The target group of this project is children at the age 3-14 years.
Worst case er således en tre-årig piges vægt, dvs. 15 kg. For enkelte situationer, eksempelvis badesituationer, hvor lillebror eller -søster bader sammen med den ældre søskende, kan det endda overvejes at bruge en endnu lavere vægt som worst case.
Worst case is thus a three-year-old girl's weight, i.e. 15 kg. For a few situations, for instance bath situations where little brother or sister bathes together with the older siblings, it may be considered to apply an even lower weight as worst case.
I alle eksponeringsscenarierne anvendes som standard et barn på 15 kilo, svarende til en alder på tre år, som er den nedre alder i målgruppen for de kosmetiske produkter til børn, der er undersøgt i dette projekt.
In all exposure scenarios a child of 15 kilos is applied as a standard equivalent to an age of three years which is the lower age in the target group of the cosmetic products for children being studied in this project.
Til risikovurderingen anvendes en standard MoS (Margin of Satety) på 100.
A standard MoS (Margin of Satety) of 100 is applied for the risk assessment.
Det er generelt accepteret, at MoS skal være mindst 100 for at et stof kan erklæres for sikkert at bruge.
It is generally accepted that MoS must be at least 100 in order that a substance can be declared as safe to apply.
Hvis man har et troværdigt dyrestudie, kan det retfærdiggøres at bruge en faktor 10 for artsforskelle (dyr til mennesker) og en faktor 10 for at medtage følsomme grupper i befolkningen - i alt en faktor 100.
If a credible animal study is available it can be justified to use a factor 10 for differences in kind (animals to humans) and a factor 10 to include sensitive groups in the population - in total a factor 100.
Der er i alt analyseret 11 produkter for et kvantitativt indhold af Kathon.
In total 11 products are analyzed for a quantitative content of Kathon.
Tabellen nedenfor angiver intervallerne for de målte koncentrationer af Kathon for de forskellige undersøgte produkttyper.
The table below states the intervals of the measured concentrations of Kathon in the different product types being studied.
Desuden er tabellen en oversigt over, hvilke typer af produkter, der er fundet Kathon i via kortlægningen.
Furthermore, the table is an overview of the product types in which Kathon is found via the study.
Den maksimalt tilladte koncentration af Kathon i kosmetiske produkter er 15 mg/kg.
The maximum permissible concentration of Kathon in cosmetic products is 15 mg/kg.
Tabel 7.2: Produkter med Kathon.
Table 7.2: Produkts with Kathon.
For de analyserede produkter er de målte koncentrationer angivet.
The measured concentrations are stated for the analyzed products.
Ingen analyser foretaget
No analyses conducted
Den daglige eksponeringsmængde - også kaldet den interne eksponering (i EU kaldet SED eller Systemic Exposure Dosage) er for en kosmetisk ingrediens den mængde af stoffet, der forventes at trænge ind i blodbanen (og dermed være systemisk disponibel) per kg kropsvægt per dag (SCCNFP 0690, 2003).
For a cosmetics constituent, the daily exposure quantity - also called the internal exposure (in the EU called SED or Systemic Exposure Dosage) is the quantity of the substance being expected to penetrate into the bloodstream (and thus being systemic disposable) per kg body weight per day (SCCNFP 0690, 2003).
Eksponeringsscenarierne, der her beregnes for Kathon, er worst case scenarier, beregnet efter retningslinierne og default-værdier i TGD (Appendix II, Table 14), samt retentionsfaktorer fra SCCNFP 0690 (2003).
The calculated exposure scenarios for Kathon are worst case scenarios, calculated according to the guidelines and default values in TGD (Appendix II, Table 14) and retention factors from SCCMFP 0690 (2003).
Retentionsfaktoren er introduceret af SCCNFP for at tage højde for produkter, der fortyndes, når de bruges og skylles af efter brug, dvs. for shampooprodukter, bodyshampoo og lingnende ”rinse-off” produkter.
The retention factor is introduced by SCCNFP to consider products being diluted when they are used and cleansed off after use, i.e. for shampoo products, body shampoo and similar “rinse-off” products.
Der er ingen data for flydende sæbe.
No data are available for liquid soap.
Her anvendes de værdier, der er brugt i forbrugerprojektet ”Kortlægning og sundheds- og miljømæssig vurdering af håndsæbe” (Larsen JR et al, 2006).
Here the values from the consumer project “Survey and health and environmental assessment of hand soap”(Larsen JR et al, 2006) are applied.
De faktorer, der indgår i beregningen, fremgår af Tabel 7-3.
The factors being a part of the calculation are seen in Table 7-3.
Anvendte faktorer i eksponeringsvurderingen.
Applied factors in the exposure assessment.
1 - antagelse, da ingen data via TGD eller SCCNFP guidelines.
1 - assumption as no data in TGD or SCCNFP guidelines.
3 - der er ingen eau de toilette produkter, der er blevet analyseret.
3 - no eau de toilette products have been analyzed.
Derfor anvendes 15 mg/kg, der er den max. tilladte koncentration.
Therefore, the maximum permissible concentration of 15 mg/kg is applied.
Som det fremgår af tabellen, findes der heller ingen data for eau de toilette.
As seen in the table no data for eau de toilette are available.
Der antages en massefylde på 1 g/liter, da eau de toilette hovedsageligt består af vand og ifølge analysen af en eau de toilette i dette projekt omkring 8% parfumestoffer.
A density of 1 g/litre is assumed as eau de toilette mainly consists of water and about 8% fragrances according to the analyse of an eau de toilette in this project.
Det antages, at eau de toilette appliceres én gang per dag.
It is assumed that eau de toilette is applied once per day.
Voksne vil typisk have en brug på 1-2 appliceringer per dag, hvorimod helt små børn må forventes at bruge væsentligt mindre.
Typically, adults will have a use of 1-2 applications per day whereas very small children may be expected to apply significantly less.
Det må antages, at pigerne når en vis alder før de begynder at bruge eau de toilette.
It may be assumed that the girls have a certain age before they start using eau de toilette.
De større børn kan bedre forventes at efterligne moderens mønster, dvs. 1-2 appliceringer per dag.
The older children can be expected to imitate the mother's behaviour, i.e. 1-2 applications per day.
Med hensyn til appliceringsmængde, så er der ikke angivet en mængde i TGD for eau de toilette.
Regarding application quantity, no quantity is stated in TGD for eau de toilette.
I stedet bruges værdien for deodorant spray på 3,0 g per applicering.
Instead the value for deodorant spray of 3.0 g per application is used.
Denne værdi er sandsynligvis væsentlig højere end den reelle værdi, idet der erfaringsmæssigt bruges mindre eau de toilette end deodorantspray.
This value is probably significantly higher than the real value as experience shows that less eau de toilette than deodorant spray is used.
Tilsvarende er der ikke angivet en standardvægt for et barn i TGD.
Correspondingly, no standard weight for a child is stated in TGD.
Der anvendes derfor som beskrevet i indledningen af kapitlet en worst case værdi på 15 kg for et barns vægt.
As described in the beginning of the chapter, a worst-case value of 15 kg for a child's weight is applied.
Den daglige eksponering beregnes vha. nedenstående formel, hvor SED (Systemic Exposure Dosage) er den daglige eksponering, A er mængden, der appliceres dagligt, C er koncentrationen af stoffet i det kosmetiske produkt, DA (Dermal Absorption) er optagelsen gennem huden udtrykt i %, Rf er retentionsfaktoren (introduceret af SCCNFP for at tage højde for ”rinse-off” produkter og bw (bodyweight) er kropsvægten for barnet.
The daily exposure is calculated by use of the formula below where SED (Systemic Exposure Dosage) is the daily exposure, A is the quantity being applied daily, C is the concentration of the substance in the cosmetics product, DA (Dermal Absorption) is the absorption through the skin indicated in %, Rf is the retention factor (introduced by SCCNFP to consider “rinse-off” products) and bw (body weight) is the body weight of the child.
Den daglige eksponering for Kathon ved brug af bodylotion for et tre-årigt barn kan således beregnes til:
The daily exposure of Kathon when using body lotion on a three-year-old child can be calculated to:
I tabellen nedenfor er den daglige eksponering (SED) for Kathon angivet for de forskellige produkttyper.
In the table below the daily exposure (SED) for Kathon is stated for the different product types.
Tabel 7.4: Daglig eksponering (SED) for Kathon for de forskellige produkttyper
Table 7.4: Daily exposure (SED) for Kathon for the different product types
Det ses, at de højeste daglige eksponeringer forekommer ved brug af eau de toilette og bodylotion.
It is seen that the highest daily exposures occur when using eau de toilette and body lotion.
Det skal dog bemærkes, at brugen af eau de toilette vurderes at være meget overvurderet, da der anvendes de samme eksponeringsværdier som for almindelig deodorant.
It must be noted that the apply of eau de toilette is assessed to be much overestimated as the same exposure values as for normal deodorant are applied.
7.1.1 Risikovurdering for Kathon
7.1.1 Risk assessment for Kathon
Risikovurderingen foretages for den kritiske effekt af Kathon, som ved akut toksicitet er ataksi og alvorlig maveirritation.
The risk assessment is conducted for the critical effect of Kathon which at acute toxicity is ataxia and serious stomach irritation.
Det antages at 100% af det Kathon, som barnet eksponeres for også optages i kroppen.
It is presumed that 100% of the Kathon to which the child is exposed will also be absorbed in the body.
Der anvendes den NOAEL-værdi som er identificeret for Kathon i sundhedsvurderingen i afsnit 6.3.2, dvs. for blandingen MI/CMI.
The applied NOAEL value is identified for Kathon in the health assessment in section 6.3.2, i.e. for the mixture MI/CMI.
Margin of Safety for Kathon ved brug af bodylotion for et tre-årigt barn, bliver således:
Margin of Safety for Kathon when using body lotion on a three-year-old child will be:
Tabel 7.5: Margin of safety (MoS) for Kathon i de forskellige produkttyper
Table 7.5: Margin of safety for Kathon for the different product types
Margin of Safety bør være over 100 for at tage højde for en sikkerhedsfaktor på 10 for ekstrapolering af data fra dyr til mennesker og en sikkerhedsfaktor på 10 for at tage højde for særligt følsomme menneskelige individer.
Margin of Safety ought to be above 100 to take account of a safety factor of 10 for extrapolation of data from animals to humans and a safety factor of 10 to take account of especially sensitive human individuals.
Beregningen viser, at sikkerhedsmargenerne ligger væsentligt over 100, selvom beregningen er foretaget som en worst case beregning, dvs. for et tre-årigt barn med høj daglig brug af bodylotion.
The calculation shows that the margins of safety are substantially above 100 even if the calculation is made as a worst case calculation, i.e. for a three-year-old child with a high daily use of body lotion.
Der er i alt analyseret 17 produkter for et kvantitativt indhold af de 26 parfumestoffer, herunder benzylalkohol.
In total 17 products are analyzed for a quantitative content of the 26 fragrances, including benzyl alcohol.
Der blev fundet benzylalkohol i 12 af de 17 analyserede produkter.
Benzyl alcohol was found in 12 of the 17 analyzed products.
Tabellen nedenfor angiver intervallerne for de målte koncentrationer af benzylalkohol for de forskellige undersøgte produkttyper.
The table below states the intervals of the measured concentrations of benzyl alcohol in the different product types being studied.
Desuden er tabellen en oversigt over, hvilke typer af produkter, der er fundet benzylalkohol i via kortlægningen.
Furthermore, the table is an overview of the product types in which benzyl alcohol is found via the study.
Højest tilladte koncentration som konserveringsmiddel i kosmetiske produkter er 1% ifølge Kosmetikbekendtgørelsen.
The maximum permissible concentration of a preservative in cosmetic products is 1% according to the Cosmetics Statutory Order.
Som parfumestof er der ingen øvre grænse.
As a fragrance there is no upper limit.
Tabel 7.6: Produkter med benzylalkohol.
Table 7.6: Products with benzyl alcohol.
Der findes ingen data for eau de toilette i TGD.
There are no data for eau de toilette in TGD.
Der findes heller ingen data for badekaviar i TGD.
Nor any data are found for bath caviar in TGD.
Der er derfor foretaget et kvalificeret gæt på en brugsfrekvens på 1 gang per uge, og for den anvendte mængde per applicering er anvendt en værdi på 25 g.
Therefore, an educated guess of an applied frequency of 1 time per week is made and for the applied quantity per application a value of 25 g is used.
I de mindste pakninger er der et indhold svarende til en lille håndfuld.
In the smallest packages the content corresponds to a small handful.
Der er derfor som worst case foretaget den antagelse, at der anvendes hele pakningen, dvs. 25 g.
As worst case it is assumed that the whole package of 25 g is used.
Tilsvarende er der ikke angivet en standard vægt for et barn i TGD.
Correspondingly, no standard weight for a child is stated in TGD.
Der anvendes således, som beskrevet i indledningen af kapitlet, 15 kg for et barns vægt.
As described in the beginning of this chapter, a value of 15 kg for a child's weight is applied.
Den daglige eksponering (SED) for benzylalkohol beregnes som beskrevet for Kathon, og giver eksempelvis følgende daglige eksponering ved brug af bodylotion for et tre-årigt barn:
The daily exposure (SED) for benzyl alcohol is calculated as described for Kathon and gives for instance the following daily exposure when using body lotion on a three-year-old child:
I tabellen nedenfor er den daglige eksponering (SED) for benzylalkohol angivet for de forskellige produkttyper.
In the table below the daily exposure (SED) for benzyl alcohol is stated for the different product types.
Tabel 7.8: Daglig eksponering (SED) for benzylalkohol for de forskellige produkttyper
Table 7.8: Daily exposure (SED) for benzyl alcohol for the different product types
Det ses, at den højeste daglige eksponering forekommer ved brug af bodylotion.
It is seen that the highest daily exposure occurs when using body lotion.
Risikovurderingen for benzylalkohol foretages for den kritiske effekt, som ved akut toksicitet er sløvhed.
The risk assessment for benzyl alcohol is conducted for the critical effect of benzyl alcohol which is lethargy at acute toxicity.
Det antages, at 100% af det benzylalkohol, som barnet eksponeres for, også optages i kroppen.
It is presumed that 100% of the benzyl alcohol to which the child is exposed will also be absorbed in the body.
Der er angivet flere NOAEL-værdier for benzylalkohol fra forskellige undersøgelser i afsnit 6.2.1 om sundhedsvurderingen af benzylalkohol.
Several NOAEL values for benzyl alcohol from different studies are stated in section 6.2.1 in the health assessment of benzyl alcohol.
Ved beregning af Margin of Safety (MoS) for benzylalkohol indsættes den udregnede daglige eksponering (= SED) i følgende formel:
When calculating Margin of Safety (MoS) for benzyl alcohol the calculated daily exposure (= SED) is placed in the following formula:
Margin of Safety for benzylalkohol ved brug af bodylotion for et tre-årigt barn, bliver således:
Margin of Safety for benzyl alcohol when using body lotion on a three-year-old child will be:
Tabel 7.9: Margin of safety (MoS) for benzylalkohol for de forskellige produkttyper
Tabel 7.9: Margin of safety for benzyl alcohol for the different product types
De beregnede Margin of Safety viser dog, at der ikke er nogen sundhedsrisiko ved brugen af produkterne i forhold til indholdet af benzylalkohol.
Therefore, it cannot be denied that other non-analyzed products may have a higher content of benzyl alcohol and thus form a potential health risk.
8.4 Anbefalinger ved køb og brug af kosmetiske produkter til børn
8.4 Recommendations on purchase and apply of cosmetic products for children
8.1 Risikovurdering på baggrund af analyseresultaterne
8.1 Risk assessment based on the analyse results
På baggrund af resultaterne af de kvantitative analyser af kosmetiske produkter til børn er der foretaget en risikovurdering af de analyserede produkter for deres indhold af Kathon og benzylalkohol.
Based on the results of the quantitative analyses of cosmetic products for children, a risk assessment of the analyzed products for their content of Kathon and benzyl alcohol is conducted.
Risikovurderingen er foretaget for den akutte toksicitet af Kathon og benzylalkohol.
The risk assessment is conducted for the acute toxicity of Kathon and benzyl alcohol.
Risikovurderingen viser, at sikkerhedsmarginen (MoS) er langt fra at blive overskredet, med en enkelt undtagelse, hvor en bodylotion/creme har et indhold af benzylalkohol, der resulterer i en sikkerhedsmargin på ca. 240.
The risk assessment shows that the Margin of Safety (MoS) is far from being exceeded, with one exception where a body lotion/cream has a content of benzyl alcohol resulting in a margin of safety of approx. 240.
Dvs. der er stadig ingen sundhedsmæssig risiko ved brugen af produkterne i forhold til indholdet af benzylalkohol.
I.e. there is still no health risk in using the products in relation to the content of benzyl alcohol.
Generelt gælder for de undersøgte produkter, at der ingen sundhedsrisiko er på baggrund af det analyserede indhold af Kathon og benzylalkohol i produkterne.
In general, the following applies for the studied products that there is no health risk based on the analyzed content of Kathon and benzyl alcohol in the products.
Det skal dog understreges, at risikovurderingen udelukkende tager udgangspunkt i indholdet af enten Kathon eller benzylalkohol i de analyserede produkter.
However, it must be emphazised that the risk assessment is solely based on the content of either Kathon or benzyl alcohol in the analyzed products.
Derudover skal det understreges, at vurderingen ikke er baseret på allergi som den kritiske effekt, jævnfør de sundhedsmæssige vurderinger i kapitel 6.
Furthermore, it must also be emphazised that the assessment is not based on allergy as the critical effect, cf. the health assessments in chapter 6.
8.2 Analyseresultaterne for emballage
8.2 The analyse results for packaging
Udvalgte produkter blev analyseret for deres indhold af tungmetaller i emballagen.
Selected products were analyzed for their content of heavy metals in the packaging material.
Alle de målte totalværdier af tungmetaller i emballagerne ligger væsentligt under de grænseværdier, der er sat for hvor store mængder metaller, der må migrere ud af legetøjet ved brug.
All the measured total values of heavy metals in the packaging materials are significantly below the threshold limits indicating how large quantities of metals that are permitted to migrate from the toys when used.
De målte totalværdier giver således ikke anledning til sundhedsmæssig bekymring i forhold til de eksisterende grænseværdier for migration af stoffer fra legetøjsmaterialer.
Thus the measured total values do not give cause for health concern in relation to the existing threshold limits for migration of substances from toys materials.
Af samme årsag blev der ikke udført migrationsanalyser for udvalgte produkter.
For the same reason no migration analyses of selected products have been conducted.
Andre produkter blev undersøgt for indhold af ftalater i emballagen.
Other products were tested for a content of phthalates in the packaging material.
Ftalattyperne, der blev identificeret var primært DEHP og DINP.
The phthalates being identified were primarily DEHP and DINP.
Det totale ftalatindhold i de undersøgte emballager var max. 31%.
The total content of phthalate in the studied packaging materials was as a maximum 31%.
Alle undersøgte produkter med et indhold af ftalater er udformet som en tegneseriefigur, dyr eller lignende, hvoraf nogle er vurderet til at være omfattet af reglerne for legetøj på baggrund af vejledende udtalelse fra Sikkerhedsstyrelsen, mens de resterende produkter er småbørnsartikler.
All the studied products with a content of phthalates are designed as a cartoon figure, animals or similar of which some are assessed to be comprised by the rules for toys based on the indicative statement of the Danish Safety Technology Authority, while the rest are defined as child care articles.
DEHP og DINP blev forbudt fra april 2007 i legetøj og småbørnsartikler til børn op til 14 år i en koncentration på over 0,1% - for DINP's vedkommende dog kun i produkter, som børn vil kunne putte i munden.
DEHP and DINP were banned from April 2007 in toys for children up to 14 years in a concentration above 0.1% - in the case of DINP only in toys which children may put into the mouth.
Kosmetiske produkter, der også er omfattet af reglerne for legetøj eller småbørnsartikler, og hvor emballagen indeholder disse ftalater, er således i uoverensstemmelse med den nye ftalatlovgivning.
Cosmetic products which are also comprised by the rules for toys and where the packaging contains phthalates are thus in discrepancy with the new phthalate legislation.