natgillin/translations-raw huggingface dataset:
Findes på http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/labelling/index_en.htm
Available on http://ec.europa.eu/consumers/sectors/cosmetics/documents/guidelines/labelling/index_en.htm
Findes på http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_labelling200802_en.pdf
Available on http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/guide_labelling200802_en.pdf
For så vidt angår produkter i samme serie, hvor den eneste forskel mellem de forskellige produkter er farvestoffet, og det ikke har indflydelse på sikkerheden, f.eks. læbestifter eller anden makeup med farve, kan det overvejes at udarbejde en kombineret rapport om de kosmetiske produkters sikkerhed, men det skal begrundes.
For products in the same range, where the only difference among different products is the colouring agent, and that has no impact on safety, e.g. for lipsticks or other colour make-up, a combined product safety report may be considered, but is to be justified.
SCCS, SCHER, SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012, http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf
SCCS, SCHER, SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012 http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf
SCCS's retningslinjer, punkt 3-7.3, s. 51.
SCCS Notes of Guidance, para 3-7.3, p. 51.
Dossieret med produktinformationer skal ajourføres efter behov og gøres let tilgængeligt i elektronisk eller andet format på den ansvarlige persons adresse, som fremgår af mærkningen, for den kompetente myndighed af hensyn til markedsovervågningen i et tidsrum af 10 år fra den dato, hvor den sidste serie af det kosmetiske produkt blev bragt i omsætning.
The product information file should be updated when necessary and kept readily accessible, in electronic or other format, at the address of the responsible person given on the label, to the competent authorities for market surveillance purposes for a period of 10 years following the placing on the market of the last batch of the product.
Ud fra et sikkerhedsmæssigt synspunkt er rapporten om det kosmetiske produkts sikkerhed som omhandlet i artikel 10, stk. 1, det vigtigste element i dossieret med produktinformationer.
The most important element of the product information file, from a safety point of view, is the cosmetic product safety report referred to in Article 10(1).
ECHA, Praktisk vejledning 2: Rapportering af »weight of evidence«, 2010, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_da.pdf
ECHA, Practical guide 2: How to report weight of evidence’, 2010, http://echa.europa.eu/documents/10162/13655/pg_report_weight_of_evidence_en.pdf
Rapporten, der som minimum bør indeholde alle de oplysninger, som fremgår af bilag I til forordning (EF) nr. 1223/2009, bør af hensyn til de kompetente myndigheder have samme eller enslydende overskrifter som i bilag I. Det kan dog være tilstrækkeligt under de enkelte overskrifter klart at henvise til et dokument, der indeholder oplysningerne, og som er let tilgængeligt i elektronisk eller trykt format.
The report, which should contain, as a minimum, all the information indicated in Annex I to Regulation (EC) No 1223/2009, should appear under the same or similar headings for ease of reference of the competent authorities. However, it may be sufficient to provide under each heading a clear reference to a document containing the information and readily available in electronic or printed format.
Disse aspekter er af afgørende betydning for at kunne foretage risikovurderingen, eftersom det er de tre afgørende trin i risikovurderingsprocessen [18].De endpoints, der skal tages i betragtning, og de nødvendige oplysninger afhænger af en række faktorer, herunder eksponeringsveje, produktets anvendelse, de fysisk-kemiske egenskaber og den mulige absorption af stoffet.
These aspects are of crucial importance in order to perform the risk assessment, as they are the three essential steps of the risk assessment process [18]. The endpoints to be considered, as well as the necessary data, depend on a number of factors, including the routes of exposure, the conditions of use of the product, the physico/chemical characteristics and the possible absorption of the substance.
Ifølge del A, nr. 8, i bilag I til forordning (EF) nr. 1223/2009 skal systemiske virkninger og sikkerhedsmarginer fremgå af sikkerhedsrapportens del A. Eftersom de er obligatoriske, skal undladelse af disse trin begrundes behørigt.
In accordance with Point 8 part A of Annex I to Regulation (EC) No 1223/2009, systemic effects and margin of safety are to be considered in Part A of the safety report. As they are mandatory, the omission of these steps is to be duly justified.
EFSA (2008) EFSA-Q-2006-160
EFSA (2008) EFSA-Q-2006-160.
Bremmer H.J., Prud’homme de Lodder L.C.H., van Engelen J.G.M., Cosmetics Fact Sheet to Assess the Risks for the Consumer, Updated version for ConsExpo 4, RIVM report 320104001/2006 (http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf)
Bremmer H.J., Prud’homme de Lodder L.C.H., van Engelen J.G.M., Cosmetics Fact Sheet to Assess the Risks for the Consumer, Updated version for ConsExpo 4, RIVM report 320104001/2006 (http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf).
CTFA & COLIPA, Guidelines On Stability Testing Of Cosmetic Products, marts 2004
CTFA & COLIPA, Guidelines On Stability Testing Of Cosmetic Products, March 2004.
Det Europæiske Kemikalieagentur (ECHA), Vejledning om identifikation og navngivning af stoffer i henhold til REACH og CLP, november 2011
European Chemicals Agency (ECHA), Guidance for identification and naming of substances under REACH and CLP, November 2011.
Det Europæiske Kemikalieagentur (ECHA), Guidance on information requirements and chemical safety assessment, kapitel R.4: Evaluation of available information, december 2011
European Chemicals Agency (ECHA), Guidance on information requirements and chemical safety assessment Chapter R.4: Evaluation of available information, December 2011.
Europa-Kommissionen, meddelelse fra Kommissionen til Europa-Parlamentet og Rådet om forbuddene mod dyreforsøg og markedsføring og status for alternative metoder i kosmetiksektoren, COM(2013) 135 final
European Commission, Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, COM(2013) 135 final.
Hall B., Tozer S., Safford B., Coroama M., Steiling W., Leneveu-Duchemin M.C., McNamara C. and Gibney M., European consumer exposure to cosmetic products, a framework for conducting population exposure assessments, Food and Chemical Toxicology, vol. 45, udg. 11, november 2007, s. 2097-2108
Hall B., Tozer S., Safford B., Coroama M., Steiling W., Leneveu-Duchemin M.C., McNamara C. and Gibney M., European consumer exposure to cosmetic products, a framework for conducting population exposure assessments, Food and Chemical Toxicology, Volume 45, Issue 11, November 2007, Pages 2097-2108.
IGHRC 2006, Guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, The Interdepartmental Group on Health Risks from Chemicals (2006), http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html
IGHRC 2006, Guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals. The Interdepartmental Group on Health Risks from Chemicals (2006), http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html Klimisch HJ, Andreae E and Tillmann U, A systematic approach for evaluating the quality of experimental and ecotoxicological data.
Kroes R., Renwick A. G., Feron V., Galli C. L., Gibney M., Greim H., Guy R. H., Lhuguenot J. C., van de Sandt J. J. M., Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), s. 2533-2562
Kroes R., Renwick A. G., Feron V., Galli C. L., Gibney M., Greim H., Guy R. H., Lhuguenot J. C., van de Sandt J. J. M., Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients, Food and Chemical Toxicology 45 (2007), 2533–2562.
2008 May; 46(5):1516-24, Epub 2007 Dec 23
2008 May; 46(5):1516-24, Epub 2007 Dec 23.
Mildau G., Burkhard A., Daphi-Weber J., Große-Damhues J., Jung J., Schuster B., Walther C., Basic Requirements for Safety Assessment of Cosmetic Products, SOFW Journal, 133 6-2007, s. 16-22
Mildau G., Burkhard A., Daphi-Weber J., Große-Damhues J., Jung J., Schuster B., Walther C., Basic Requirements for Safety Assessment of Cosmetic Products, SOFW Journal, 133 6-2007, pp. 16-22.
Series on Testing and Assessment No. 80
Series on Testing and Assessment, No 80. Paris
Series on Testing and Assessment No. 102
Series on Testing and Assessment, No 102. Paris
Pauwels M., Rogiers V., Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), s. 260-274.
Pauwels M., Rogiers V., Human Health Safety Evaluation of Cosmetics in the EU: A Legally Imposed Challenge to Science, Toxicology and Applied Pharmacology, 243 (2010), pp. 260-274.
SCCS (Den Videnskabelige Komité for Forbrugersikkerhed), Guidance on safety assessment of nanomaterials in cosmetics, SCCS/1484/12
SCCS (Scientific Committee on Consumer Safety), Guidance on safety assessment of nanomaterials in cosmetics, SCCS/1484/12.
SCCS's retningslinjer for tests af kosmetiske stoffer og deres sikkerhedsevalueringer, 8. udg., SCCS/1501/12
SCCS, The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th Revision, SCCS/1501/12.
SCCS, SCHER og SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012
SCCS, SCHER and SCENIHR, Toxicity and Assessment of Chemical Mixtures, 2012.
»Mindsteholdbarhedsdatoen« er den dato, indtil hvilken det kosmetiske produkt under hensigtsmæssige opbevaringsvilkår bibeholder sin oprindelige virkning og forbliver sikkert. Holdbarhed efter åbning er en angivelse af, hvor lang tid efter åbning det kosmetiske produkt kan anvendes uden skade for forbrugeren. Se »Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): LABELLING OF PRODUCT DURABILITY: »PERIOD OF TIME AFTER OPENING«.
The ‘date of minimum durability’ is the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain safe; the PAO is the period of time after opening for which the product can be used without any harm to the consumer. See ‘Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): Labelling of product durability: “period of time after opening” ’.
Klimisch, E. Andreae og U. Tillmann (1997), A systematic approach for evaluating the quality of experimental and ecotoxicological data, Regul Toxicol Pharmacol 25:1-5.
Klimisch, E. Andreae and U. Tillmann (1997), A systematic approach for evaluating the quality of experimental and ecotoxicological data. Regul Toxicol Pharmacol 25:1-5.
IGHRC 2006, Guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, The Interdepartmental Group on Health Risks from Chemicals (2006), http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html
IGHRC, Guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals. The Interdepartmental Group on Health Risks from Chemicals (2006), http://www.silsoe.cranfield.ac.uk/ieh/ighrc/ighrc.html
om bemyndigelse af Rumænien til fortsat at anvende en særlig foranstaltning, der fraviger artikel 193 i direktiv 2006/112/EF om det fælles merværdiafgiftssystem
authorising Romania to continue to apply a special measure derogating from Article 193 of Directive 2006/112/EC on the common system of value added tax
Ved brev registreret i Kommissionens Generalsekretariat den 13. marts 2013 anmodede Rumænien om tilladelse til at forlænge anvendelsen af en særlig foranstaltning, der fraviger artikel 193 i direktiv 2006/112/EF for så vidt angår leverancer af træprodukter.
By letter registered with the Secretariat-General of the Commission on 13 March 2013, Romania requested authorisation for the extension of a special measure derogating from Article 193 of Directive 2006/112/EC in relation to supplies of wood products.
I overensstemmelse med artikel 395, stk. 2, andet afsnit, i direktiv 2006/112/EF underrettede Kommissionen ved brev af 17. juni 2013 de øvrige medlemsstater om Rumæniens anmodning.
In accordance with the second subparagraph of Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States by letter dated 17 June 2013 of the request made by Romania.
Ved brev af 18. juni 2013 underrettede Kommissionen Rumænien om, at den var i besiddelse af alle de oplysninger, som den fandt nødvendige for at kunne vurdere anmodningen.
By letter dated 18 June 2013, the Commission notified Romania that it had all the information it considered necessary for appraisal of the request.
I artikel 193 i direktiv 2006/112/EF fastsættes det, at det generelt påhviler den afgiftspligtige person, som leverer varerne eller ydelserne, at betale merværdiafgiften (momsen) til afgiftsmyndighederne.
Article 193 of Directive 2006/112/EC provides that the taxable person supplying the goods or services is, as a general rule, liable for the payment of value added tax (VAT) to the tax authorities.
Med Rådets gennemførelsesafgørelse 2010/583/EU [2] fik Rumænien tilladelse til at anvende en foranstaltning, der fraviger artikel 395 i direktiv 2006/112/EF, med henblik på at udpege modtageren af leverancer af træprodukter som den momsbetalingspligtige person.
Council Implementing Decision 2010/583/EU [2] authorised Romania to apply a derogating measure pursuant to Article 395 of Directive 2006/112/EC in order to designate the recipient as the person liable for the payment of VAT in the case of supplies of wood products by taxable persons.
Før den hidtidige tilladelse til at anvende en ordning for omvendt betalingspligt i forbindelse med leverancer af træ havde Rumænien oplevet problemer på træmarkedet på grund af markedets art og de involverede virksomheder.
Prior to the former authorisation to apply reverse charge to the supplies of wood, Romania had encountered problems in the timber market because of the nature of the market and the businesses involved.
Denne sektor omfatter et stort antal små virksomheder, som de rumænske myndigheder har fundet det vanskeligt at kontrollere.
There is a large number of small enterprises in this sector which the Romanian authorities have found difficult to control.
Ved at udpege modtageren som den momsbetalingspligtige person er det ifølge de rumænske myndigheder lykkedes at forhindre momsunddragelse og momsundgåelse, og denne foranstaltning er derfor fortsat berettiget.
Designating the recipient as the person liable for the payment of VAT has, according to the Romanian authorities, had the effect of preventing tax evasion and avoidance in this sector and therefore remains justified.
Foranstaltningen står i rimeligt forhold til de tilstræbte mål, da den ikke skal anvendes generelt, men kun for meget bestemte transaktioner inden for en sektor, hvor der er betydelige problemer med momsunddragelse eller -undgåelse.
The measure is proportionate to the objectives pursued since it is not intended to apply generally, but only to very specific operations in a sector which poses considerable problems of tax evasion or avoidance.
Efter Kommissionens opfattelse forventes foranstaltningen ikke at få negative konsekvenser for bekæmpelsen af svig i detailsektoren eller i andre sektorer eller medlemsstater.
The measure should not, in the Commission’s view, have any adverse impact on the prevention of fraud at the retail level or in other sectors or in other Member States.
Tilladelsen bør være begrænset i tid indtil den 31. december 2016.
The authorisation should be limited in time until 31 December 2016.
Såfremt Rumænien anmoder om en yderligere forlængelse efter 2016, bør der senest den 1. april 2016 indsendes en rapport til Kommissionen sammen med anmodningen om forlængelse.
In the event that Romania requires a further extension beyond 2016, a report together with the extension request should be submitted to the Commission no later than 1 April 2016.
På baggrund af de erfaringer, der gøres frem til denne dato, bør det vurderes, om fravigelsen fortsat er berettiget.
In light of the experience gained up to that date, an assessment should be made on whether or not the derogation remains justified.
Fravigelsen har ingen negative konsekvenser for Unionens egne indtægter hidrørende fra moms —
The derogation has no adverse impact on the Union's own resources accruing from VAT,
Uanset artikel 193 i direktiv 2006/112/EF bemyndiges Rumænien herved til indtil den 31. december 2016 at udpege den afgiftspligtige person, til hvem de varer eller tjenesteydelser, der er omhandlet i artikel 2 i denne afgørelse, leveres, som den afgiftsbetalingspligtige person.
By way of derogation from Article 193 of Directive 2006/112/EC, Romania is hereby authorised until 31 December 2016 to designate the taxable person to whom the supplies of goods or services referred to in Article 2 of this Decision are made as the person liable for the payment of the tax.
Fravigelsen i henhold til artikel 1 finder anvendelse på afgiftspligtige personers leverancer af træprodukter, herunder træ på rod, rundtræ eller kløvet arbejdstræ, brænde, tømmerprodukter samt firkantet eller tilhugget træ og træ i rå eller forarbejdet stand eller i form af halvfabrikata.
The derogation provided for in Article 1 shall apply to supplies of wood products by taxable persons including standing timber, round or cleft working wood, fuel wood, timber products, as well as square edged or chipped wood and wood in the rough, processed or semi-manufactured wood.
Enhver anmodning om forlængelse af den i denne afgørelse omhandlede foranstaltning indgives til Kommissionen senest den 1. april 2016 ledsaget af en rapport om virkningen af foranstaltningen og en vurdering af risikoen for svig inden for træsektoren.
Any request for the extension of the measure provided for in this Decision shall be submitted to the Commission no later than 1 April 2016, and shall be accompanied by a report which includes an assessment of the efficiency of the measure and an evaluation of the risk of fraud in the wood sector.
Rådets gennemførelsesafgørelse 2010/583/EU af 27. september 2010 om tilladelse til Rumænien til at indføre en særlig foranstaltning, der fraviger artikel 193 i direktiv 2006/112/EF om det fælles merværdiafgiftssystem (EUT L 256 af 30.9.2010, s. 27).
Council Implementing Decision 2010/583/EU of 27 September 2010 authorising Romania to introduce a special measure derogating from Article 193 of Directive 2006/112/EC on the common system of value added tax (OJ L 256, 30.9.2010, p. 27).
om bemyndigelse af Luxembourg til at indføre en særlig foranstaltning, der fraviger artikel 285 i direktiv 2006/112/EF om det fælles merværdiafgiftssystem
authorising Luxembourg to introduce a special measure derogating from Article 285 of Directive 2006/112/EC on the common system of value added tax
Ved brev registreret i Kommissionens Generalsekretariat den 24. oktober 2012 anmodede Luxembourg om tilladelse til at anvende en foranstaltning, der fraviger artikel 285 i direktiv 2006/112/EF, og som giver Luxembourg mulighed for at momsfritage afgiftspligtige personer, hvis årlige omsætning ikke overstiger 25000 EUR. Ved hjælp af denne foranstaltning vil disse afgiftspligtige personer kunne være fritaget for alle eller nogle af de forpligtelser, der vedrører moms, som omhandlet i afsnit XI, kapitel 2-6, i direktiv 2006/112/EF.
By letter registered with the Secretariat-General of the Commission on 24 October 2012, Luxembourg requested authorisation to apply a measure derogating from Article 285 of Directive 2006/112/EC, allowing Luxembourg to exempt from value added tax (VAT) taxable persons whose annual turnover is no higher than EUR 25000. Through that measure, those taxable persons would be exempted from all or some of the obligations in relation to VAT referred to in Chapters 2 to 6 of Title XI of Directive 2006/112/EC.
I overensstemmelse med artikel 395, stk. 2, i direktiv 2006/112/EF underrettede Kommissionen de øvrige medlemsstater om Luxembourgs anmodning ved brev af 9. november 2012.
In accordance with Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States of the request made by Luxembourg by letter dated 9 November 2012.
Ved brev af 12. november 2012 underrettede Kommissionen Luxembourg om, at den rådede over alle nødvendige oplysninger for at kunne vurdere anmodningen.
By letter dated 12 November 2012, the Commission notified Luxembourg that it had all the information necessary to consider the request.
Ifølge artikel 285 i direktiv 2006/112/EF kan de medlemsstater, som ikke har benyttet muligheden i artikel 14 i Rådets andet direktiv 67/228/EØF [2], indrømme afgiftsfritagelse til afgiftspligtige personer, hvis årlige omsætning højst er lig med 5000 EUR eller modværdien heraf i national valuta, ligesom de kan indføre en gradvis nedsættelse af afgiften for afgiftspligtige personer, hvis årlige omsætning overstiger det loft, de har fastsat med henblik på anvendelsen af afgiftsfritagelse.
According to Article 285 of Directive 2006/112/EC, Member States, which have not exercised the option under Article 14 of Second Council Directive 67/228/EEC [2], may exempt from VAT taxable persons whose annual turnover is no higher than EUR 5000 or the equivalent in national currency and may also grant graduated tax relief to taxable persons whose annual turnover exceeds the ceiling fixed by them for its application.
Luxembourg har underrettet Kommissionen om, at afgiftspligtige personer, hvis årlige omsætning ikke overstiger 10000 EU for øjeblikket er momsfritaget, og at landet gør brug af muligheden for gradvis afgiftsnedsættelse for afgiftspligtige personer, hvis årlige omsætning er mellem 10000 og 25000 EUR. Luxembourg har anmodet om bemyndigelse til en fravigelsesforanstaltning, hvorefter afgiftspligtige personer, hvis årlige omsætning ikke overstiger 25000 EUR, momsfritages.
Luxembourg has informed the Commission that it currently exempts from VAT taxable persons whose annual turnover is no higher than EUR 10000 and that it makes use of the option of granting graduated tax relief with respect to taxable persons whose annual turnover is between EUR 10000 and EUR 25000. Luxembourg has requested the authorisation to exempt from VAT, as a derogating measure, taxable persons whose annual turnover is no higher than EUR 25000.
En højere tærskel for den særlige ordning er en forenklingsforanstaltning, da den kan mindske de mindste virksomheders momsforpligtelser markant og gøre det muligt for Luxembourg at afskaffe ordningen med gradvis afgiftsnedsættelse, som belaster virksomhederne.
A higher threshold for the special scheme is a simplification measure, in so far as it may significantly reduce the VAT obligations of small businesses and would enable Luxembourg to cease applying the graduated tax relief scheme that is burdensome for businesses.
Afgiftspligtige personer bør stadig kunne vælge den normale momsordning.
Taxable persons should be still able to opt for the normal VAT arrangements.