natgillin/translations-raw huggingface dataset:
I henhold til artikel 20, stk. 1, i forordning (EF) nr. 33/2008 og efter anmodning fra Kommissionen forelagde EFSA sin konklusion om propisochlor for Kommissionen den 9. september 2010 [6] baseret på de data, der var fremlagt i henhold til forordning (EF) nr. 33/2008.
In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on propisochlor to the Commission on 9 September 2010 [6] based on data submitted in accordance with Regulation (EC) No 33/2008.
Udkastet til vurderingsrapport, den supplerende rapport og EFSA's konklusion er blevet behandlet af medlemsstaterne og Kommissionen i Den Stående Komité for Fødevarekæden og Dyresundhed, og behandlingen blev afsluttet den 24. marts 2011 med Kommissionens reviderede vurderingsrapport om propisochlor.
The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 24 March 2011 in the format of the Commission review report for propisochlor.
Det var navnlig ikke muligt at gennemføre en pålidelig vurdering af risikoen for forbrugerne og beslutte, hvorledes en restkoncentration for propisochlor og dets metabolitter skal defineres, fordi der mangler data om den toksikologiske relevans af flere metabolitter (M2 [7], M7 [8], M12 [9], M14 [10], M17 [11], M20 [12], M22 [13] og M35 [14].
In particular, it was not possible to perform a reliable consumer risk assessment and to conclude on a residue definition for propisochlor and its metabolites due to a lack of data on the toxicological relevance of several metabolites (M2 [7], M7 [8], M12 [9], M14 [10], M17 [11], M20 [12], M22 [13] and M35 [14].
Endvidere kan skadelige virkninger for grundvandet ikke udelukkes for så vidt angår en række metabolitter (M1 [15], M2, M5 [16], M7 og M9 [17] af ukendt toksikologisk og økotoksikologisk relevans, af hvilke indholdet oversteg den højeste tilladte koncentration på 0,1 μg/l, der er fastsat ved Rådets direktiv 98/83/EF af 3. november 1998 om kvaliteten af drikkevand [18], i flere opstillede scenarier for udvaskningen til grundvandet.
In addition, harmful effects on groundwater cannot be excluded for several metabolites (M1 [15], M2, M5 [16], M7 and M9 [17] of unknown toxicological and ecotoxicological relevance whose levels exceeded the maximum permissible concentration of 0,1 μg/l as laid down by Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption [18] in several model scenarios for groundwater leaching.
Endelig forelå der ikke tilstrækkeligt med oplysninger til at kunne drage konklusioner om jords, sedimenters og grundvands eksponering for den vigtige jordmetabolit M9 og afslutte vurderingen af risikoen for vandorganismer.
Finally, the data available were not sufficient to conclude on the soil, sediment and groundwater exposure for the major soil metabolite M9 and to finalise the risk assessment for aquatic organisms.
Kommissionen opfordrede ansøgeren til at kommentere resultaterne af det målrettede peer review.
The Commission invited the applicant to submit its comments on the results of the focused peer review.
Kommissionen opfordrede endvidere i overensstemmelse med artikel 21, stk. 1, i forordning (EF) nr. 33/2008 ansøgeren til at fremsætte bemærkninger til udkastet til revideret vurderingsrapport.
Furthermore, in accordance with Article 21(1) of Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report.
Selv med de af ansøgeren fremsatte argumenter kan de påpegede problemer dog ikke siges at være løst, og de vurderinger, der er foretaget på baggrund af de oplysninger, der er forelagt i henhold til forordning (EF) nr. 33/2008 og evalueret på EFSA's møder, har ikke underbygget forventningen om, at plantebeskyttelsesmidler, der indeholder propisochlor, under de foreslåede betingelser for anvendelse generelt opfylder kravene i artikel 5, stk. 1, litra a) og b), i direktiv 91/414/EØF.
However, despite the arguments put forward by the applicant, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted in accordance with Regulation (EC) No 33/2008 and evaluated during the meetings of the Authority have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing propisochlor satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Propisochlor bør derfor ikke optages i bilag I til direktiv 91/414/EØF.
Propisochlor should therefore not be included in Annex I to Directive 91/414/EEC.
Denne afgørelse er ikke til hinder for, at der kan indgives en ny ansøgning vedrørende propisochlor i henhold til artikel 6, stk. 2, i direktiv 91/414/EØF og kapitel II i forordning (EF) nr. 33/2008.
This Decision does not prejudice the submission of a further application for propisochlor pursuant to Article 6(2) of Directive 91/414/EEC and Chapter II of Regulation (EC) No 33/2008.
Af hensyn til klarheden bør oplysningerne vedrørende propisochlor i bilaget til beslutning 2008/941/EF udgå.
In the interest of clarity, the entry for propisochlor in the Annex to Decision 2008/941/EC should be deleted.
Propisochlor optages ikke i bilag I til direktiv 91/414/EØF som aktivstof.
Propisochlor shall not be included as active substance in Annex I to Directive 91/414/EEC.
godkendelser af plantebeskyttelsesmidler, der indeholder propisochlor, trækkes tilbage senest den 27. oktober 2011
authorisations for plant protection products containing propisochlor are withdrawn by 27 October 2011;
der fra datoen for offentliggørelse af denne afgørelse ikke gives godkendelse eller forlænget godkendelse af plantebeskyttelsesmidler, der indeholder propisochlor.
no authorisations for plant protection products containing propisochlor are granted or renewed from the date of publication of this Decision.
Eventuelle frister, som medlemsstaterne indrømmer i henhold til artikel 4, stk. 6, i direktiv 91/414/EØF, skal være så korte som muligt og skal udløbe senest den 27. oktober 2012.
Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire on 27 October 2012 at the latest.
I bilaget til beslutning 2008/941/EF udgår oplysningerne vedrørende »propisochlor«.
In the Annex to Decision 2008/941/EC, the entry for ‘propisochlor’ is deleted.
Den Europæiske Fødevaresikkerhedsmyndighed: »Conclusion on the peer review of the pesticide risk assessment of the active substance propisochlor«. EFSA Journal 2010; 8(9):1769.
‘European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance propisochlor’, EFSA Journal 2010; 8(9):1769.
Tilgængelig online på www.efsa.europa.eu/
Available online: www.efsa.europa.eu
2-[(2-ethyl-6-methylphenyl) (isopropoxymethyl)amino]-2-oxoethansulfonsyre.
2-[(2-ethyl-6-methylphenyl) (isopropoxymethyl)amino]-2-oxoethane sulfonic acid.
(2-[(2-ethyl-6-methylphenyl) (isopropoxymethyl)amino]-2-oxoethylsulfinyl)eddikesyre.
(2-[(2-ethyl-6-methylphenyl) (isopropoxymethyl)amino]-2-oxoethylsulfinyl) acetic acid.
Uidentificeret forbindelse i foder af majs og i solsikkefrø.
Unidentified compound in maize forage and sunflower seeds.
3-(2-[(2-ethyl-6-methylphenyl)amino]-2-oxoethylsulfinyl)-2-hydroxypropansyre.
3-(2-[(2-ethyl-6-methylphenyl)amino]-2-oxoethylsulfinyl)-2-hydroxypropanoic acid.
N-(2-ethyl-6-methylphenyl)-2-(hexopyransyloxy)-N-[(propan-2-yloxy)methyl]acetamid.
N-(2-ethyl-6-methylphenyl)-2-(hexopyranosyloxy)-N-[(propan-2-yloxy)methyl]acetamide.
Methyl3-[(2-(2-ethyl-6-methylphenyl)[(propan-2-yloxy)methyl]amino-2-oxoethyl)sulfinyl]-2-hydroxypropanoat.
methyl3-[(2-(2-ethyl-6-methylphenyl)[(propan-2-yloxy)methyl]amino-2-oxoethyl)sulfinyl]-2-hydroxypropanoate.
Uidentificeret forbindelse i majskorn, sukkerroer og solsikkefrø.
Unidentified compound in maize grains, sugar beet roots and sunflower seeds.
Uidentificeret forbindelse i solsikkefrø.
unidentified compound in sunflower seeds.
2-[(2-ethyl-6-methylphenyl) amino]-2-oxoethansulfonsyre.
2-[(2-ethyl-6-methylphenyl) amino]-2-oxoethane sulfonic acid.
N-(2-ethyl-6-methylphenyl)-2-hydroxy-N-(isopropoxymethyl)acetamid.
N-(2-ethyl-6-methylphenyl)-2-hydroxy-N-(isopropoxymethyl)acetamide.
Dimer af N-(2-ethyl-6-methylphenyl)-N-(isopropoxymethyl)-2-(mercapto)acetamid.
dimer of N-(2-ethyl-6-methyl phenyl)-N-(isopropoxymethyl)-2-(mercapto) acetamide.
af 28. april 2011
of 28 April 2011
om opstilling af miljøkriterier for tildeling af EU-miljømærket til maskinopvaskemidler
on establishing the ecological criteria for the award of the EU Ecolabel to detergents for dishwashers
under henvisning til Europa-Parlamentets og Rådets forordning (EF) nr. 66/2010 af 25. november 2009 om EU-miljømærket [1], særlig artikel 8, stk. 2,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel [1], and in particular Article 8(2) thereof,
I medfør af forordning (EF) nr. 66/2010 kan produkter, hvis miljøbelastning er nedbragt gennem hele deres livscyklus, få tildelt EU's miljømærke.
Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.
(2) Forordning (EF) nr. 66/2010 foreskriver, at der fastsættes specifikke EU-miljømærkekriterier for hver produktgruppe.
Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
Der er fastsat miljøkriterier med tilhørende vurderings- og verifikationskrav for maskinopvaskemidler i Kommissionens beslutning 1999/427/EF [2].
Commission Decision 1999/427/EC [2] has established the ecological criteria as well as the related assessment and verification requirements for detergents for dishwashers.
Efter gennemgang af denne beslutnings kriterier blev der ved Kommissionens beslutning 2003/31/EF [3] fastsat reviderede kriterier, der er gyldige til den 30. april 2011.
Following the review of the criteria set out in that Decision, Commission Decision 2003/31/EC [3] has established revised criteria which are valid until 30 April 2011.
Disse kriterier er nu igen blevet gennemgået i lyset af den tekniske udvikling.
Those criteria have been further reviewed in the light of technological developments.
Gennemgangen har vist, at det er nødvendigt at ændre produktgruppens definition ved at tilføje en ny undergruppe af produkter og opstille nye miljøkriterier.
It results from the review that it is necessary to modify the definition of the product group so as to include a new sub-product group and to establish new criteria.
De nye kriterier og de dertil hørende vurderings- og verifikationskrav bør gælde i fire år efter vedtagelsen af denne afgørelse.
Those new criteria, as well as the related assessment and verification requirements, should be valid for 4 years from the date of adoption of this Decision.
Beslutning 2003/31/EF bør erstattes af hensyn til klarheden.
Decision 2003/31/EC should therefore be replaced for reasons of clarity.
Producenter, hvis produkter har fået tildelt miljømærket for maskinopvaskemidler på grundlag af kriterierne i beslutning 2003/31/EF, bør indrømmes en overgangsperiode, der giver dem tid nok til at tilpasse deres produkter, så de opfylder de reviderede kriterier og krav.
A transitional period should be allowed for producers whose products have been awarded the Ecolabel for detergents for dishwashers on the basis of the criteria set out in Decision 2003/31/EC, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements.
Indtil gyldighedsperioden for beslutning 2003/31/EF udløber, bør producenterne desuden kunne indgive ansøgninger enten efter denne beslutnings kriterier eller efter kriterierne i nærværende afgørelse.
Producers should also be allowed to submit applications based on the criteria set out in Decision 2003/31/EC or on the criteria set out in this Decision until the lapse of validity of that Decision.
Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra det udvalg, der er nedsat ved artikel 16 i forordning (EF) nr. 66/2010 —
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
Produktgruppen »maskinopvaskemidler« omfatter maskinopvaskemidler og produkter, der benyttes som skyllemidler, uanset om de foreligger i pulverform, væskeform eller enhver anden form, og hvis de forudsættes bragt i omsætning og anvendt udelukkende i automatiske husholdningsopvaskemaskiner og i automatiske opvaskemaskiner, der er til erhvervsmæssig brug, men i størrelse og anvendelsesmåde svarer til husholdningsopvaskemaskiner.
The product group ‘Detergents for Dishwashers’ shall comprise detergents for dishwashers and products used as rinse aids, whether in powder, liquid or any other form, which are intended to be marketed and used exclusively in automatic domestic dishwashers and in automatic dishwashers for professional use, the size and usage of which is similar to that of domestic dishwashers.
I denne beslutning forstås ved: »stof«
For the purpose of this Decision, the following definitions shall apply:
et grundstof eller en naturlig eller industrielt fremstillet forbindelse, som det indgår i, herunder tilsætningsstoffer, der er nødvendige for at bevare produkternes stabilitet, og urenheder, der stammer fra fremstillingsprocessen, men ikke opløsningsmidler, som kan udskilles, uden at det påvirker stoffets stabilitet eller ændrer dets sammensætning.
‘Substance’ means a chemical element and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Et maskinopvaskemiddel kan kun få tildelt EU-miljømærket i medfør af forordning (EF) nr. 66/2010, hvis det tilhører produktgruppen »maskinopvaskemidler« som defineret i artikel 1 og opfylder kriterierne i bilaget.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a detergent for dishwashers shall fall within the product group ‘Detergents for Dishwashers’ as defined in Article 1, and shall comply with the criteria set out in the Annex to this Decision.
Kriterierne for produktgruppen »maskinopvaskemidler« og de dertil hørende vurderings- og verifikationskrav gælder i fire år efter vedtagelsen af denne afgørelse.
The criteria for the product group ‘Detergents for Dishwashers’, as well as the related assessment and verification requirements, shall be valid for 4 years from the date of adoption of this Decision.
Produktgruppen »maskinopvaskemidler« får til administrative formål tildelt kodenummer »015«.
For administrative purposes the code number assigned to the product group ‘Detergents for dishwashers’ shall be ‘015’.
Beslutning 2003/31/EF ophæves.
Decision 2003/31/EC is repealed.
Uanset artikel 6 bedømmes EU-miljømærkeansøgninger for produkter i produktgruppen »maskinopvaskemidler« på de betingelser, der er fastlagt i beslutning 2003/31/EF, hvis de indgives før vedtagelsesdatoen for denne afgørelse.
By derogation from Article 6, applications for the EU Ecolabel for products falling within the product group ‘Detergents for Dishwashers’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2003/31/EC.
EU-miljømærkeansøgninger, der indgives for produkter i produktgruppen »maskinopvaskemidler« efter vedtagelsesdatoen for denne beslutning, men senest den 30. april 2011, kan enten bygge på kriterierne i beslutning 2003/31/EF eller på kriterierne i nærværende afgørelse.
Applications for the EU Ecolabel for products falling within the product group ‘Detergents for Dishwashers’ submitted from the date of adoption of this Decision but by 30 April 2011 at the latest may be based either on the criteria set out in Decision 2003/31/EC or on the criteria set out in this Decision.
Disse ansøgninger bedømmes efter de kriterier, de bygger på.
Those applications shall be evaluated in accordance with the criteria on which they are based.
Når miljømærket tildeles på grundlag af en ansøgning, der er bedømt efter kriterierne i beslutning 2003/31/EF, kan det anvendes i 12 måneder fra vedtagelsesdatoen for nærværende afgørelse.
Where the Ecolabel is awarded on the basis of an application evaluated according to the criteria set out in Decision 2003/31/EC, that Ecolabel may be used for 12 months from the date of adoption of this Decision.
Udfærdiget i Bruxelles, den 28. april 2011.
Done at Brussels, 28 April 2011.
EFT L 167 af 2.7.1999, s. 38.
OJ L 167, 2.7.1999, p. 38.
Kriterierne sigter især mod at fremme produkter, der belaster vandøkosystemerne mindre, som indeholder en begrænset mængde farlige stoffer, og hvis præstationer er afprøvet.
The criteria aim, in particular, at promoting products that have a reduced impact on aquatic ecosystems, contain a limited amount of hazardous substances and whose performance has been tested.
Kriterierne omfatter følgende områder:
These criteria cover the following areas:
Samlet kemikalieindhold
Total chemicals.
Stoffer eller blandinger, der ikke må anvendes eller kun må anvendes i begrænset omfang
Excluded or limited substances or mixtures.
Toksicitet for organismer, der lever i vand: kritisk fortyndingsvolumen (Critical Dilution Volume: CDV)
Toxicity to aquatic organisms: Critical Dilution Volume.
Organiske stoffers bionedbrydelighed
Biodegradability of organics.
Vaskeevne
Washing performance.
Emballagekrav
Packaging requirements.
Forbrugeroplysning
Consumer information.
Oplysninger på EU-miljømærket.
Information appearing on the EU Ecolabel.
Vurdering og verifikation
Assessment and verification
Der er anført specifikke vurderings- og verifikationskrav ved hvert kriterium.
The specific assessment and verification requirements are indicated within each criterion.
Når ansøgeren skal forelægge erklæringer, dokumentation, analyse- og prøvningsresultater eller andet belæg for, at kriterierne er opfyldt, er det underforstået, at belægget efter forholdene kan stamme fra ansøgeren og/eller dennes leverandør(er) og/eller disses leverandør(er) osv.
Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, it is understood that these may originate from the applicant, and/or his supplier(s), and/or their supplier(s), etc., as appropriate.
Prøvning udføres så vidt muligt af laboratorier, som opfylder de generelle krav i standard EN ISO 17025 eller tilsvarende.
Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.
Tillæg I henviser til databasen for vaskemiddelingredienser (Detergent Ingredients Database, DID-listen), som omfatter de mest udbredte opvaskemiddelingredienser.
Appendix I makes reference to the detergent ingredient database (DID list) which contains the most widely used ingredients used in detergent formulations.
Den skal anvendes som grundlag for beregningerne af det kritiske fortyndingsvolumen og til vurderingen af ingrediensernes bionedbrydelighed.
It shall be used for deriving the data for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of the ingredients.
For stoffer, der ikke optræder på DID-listen, gives der anvisninger på, hvordan de relevante data beregnes eller ekstrapoleres.
For substances not present on the DID list, guidance is given on how to calculate or extrapolate the relevant data.
Den seneste version af DID-listen kan fås på EU-miljømærkets websted eller via de enkelte ansvarlige organers websteder.
The latest version of the DID list is available from the EU Ecolabel website or via the websites of the individual competent bodies.
Målegrænser
Measurement thresholds
Indholdsstoffer, hvis koncentration i præparatet overstiger 0,010 vægtprocent, skal opfylde miljøkriterierne.
Constituent substances the concentration of which exceeds 0,010 % by weight of the preparation shall comply with the ecological criteria.
Med undtagelse af kriterium 2b) om indholdet af farlige stoffer og blandinger, skal konserverings-, farve- og duftstoffer opfylde kriterierne, uanset hvilken koncentration de forekommer i.
For preservatives, colouring agents and fragrance compliance with the criteria is required regardless of their concentration except for criterion 2(b) on the content of hazardous substances and mixtures.
Indholdsstoffer defineres som alle stoffer i produktet, inklusive tilsætningsstoffer (f.eks. konserveringsstoffer eller stabilisatorer) i ingredienserne.
Ingoing substances are defined as all substances in the product including additives (e.g. preservatives or stabilizers) in the ingredients.
Urenheder, der stammer fra råmaterialefremstillingen, og som er til stede i den endelige sammensætning i koncentrationer på mere end 0,010 vægtprocent, skal også opfylde kriterierne.
Impurities resulting from the raw material production, which are present in concentrations > 0,010 % by weight of the final formulation shall also comply with the criteria.
En vandopløselig beskyttelsesfilm om produktet, der ikke skal fjernes inden opvasken, skal anses for en bestanddel i produktet for alle kravs vedkommende.
If the product has a water-soluble foil intended not to be removed before washing, the foil must be considered to be part of the product formulation in all requirements.
Den funktionelle enhed er den mængde opvaskemiddel, som er nødvendig for at rengøre tolv normalt snavsede kuverter (som defineret ved DIN- eller ISO-standarder).
The functional unit shall be the quantity of product required to wash 12 place settings with a standard soil (as defined by DIN or ISO standards).
Referencedosering
Reference dosage
Den mængde opvaskemiddel, som producenten anbefaler forbrugeren at anvende til opvask af tolv normalt snavsede kuverter, antages som referencedosering under normale forhold, som fastlagt i IKW's opvaskeevnetest, jf. kriterium 5.
The dosage recommended by the manufacturer to consumers for normally soiled dishes and 12 place settings is taken as a reference dosage under standard conditions, as laid down in the IKW washing performance test referred to in criterion 5.
Krav til vurdering og verifikation af 2. funktionel enhed og 3. referencedosering: Hele recepten skal forelægges for det ansvarlige organ, herunder handelsnavn, kemisk navn, CAS-nr., DID-nr.
Requirements relating to assessment and verification of (2) Functional unit and (3) Reference dosage: The full formulation comprising trade name, chemical name, CAS No, DID No [1], ingoing quantity including and excluding water, and function of all the ingoing ingredients (regardless of concentration) in the product must be submitted to the competent body.
[1], indgående mængde inklusive og eksklusive vand samt funktionen af alle indgående ingredienser (uanset koncentration) i produktet.
A sample of the artwork including dosage recommendations must be submitted to the competent body.
Der skal forelægges en prøve på etiketten med doseringsanbefalingerne for det ansvarlige organ.Der skal for hver ingrediens forelægges sikkerhedsdatablade for det ansvarlige organ i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 [2].DID-listen kan findes på EU-miljømærkets websted: http://ec.europa.eu/environment/ecolabel/ecolabelled_products/categories/did_list_en.htm
Safety data sheets for each ingredient shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2].The DID list can be found on the EU Ecolabel website: http://ec.europa.eu/environment/ecolabel/ecolabelled_products/categories/did_list_en.htm
KRITERIER FOR EU-MILJØMÆRKET
EU ECOLABEL CRITERIA
Kriterium 1 —
Criterion 1 –
Samlet kemikalieindhold
Total chemicals