natgillin/translations-raw huggingface dataset:
Foranstaltningerne i denne forordning er i overensstemmelse med udtalelse fra Den Stående Komité for Fødevarekæden og Dyresundhed —
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 13(2) and Article 78(2) thereof,
Godkendelse af aktivstof
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC [2] is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011.
Aktivstoffet ipconazol, som opført i bilag I, godkendes på de betingelser, der er fastsat i samme bilag.
For ipconazole the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/20/EC [3].
Revurdering af plantebeskyttelsesmidler
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 30 March 2007 an application from Kureha GmbH for the inclusion of the active substance ipconazole in Annex I to Directive 91/414/EEC.
Om nødvendigt ændrer eller tilbagekalder medlemsstaterne i henhold til forordning (EU) nr. 1107/2009 senest den 28. februar 2015 eksisterende godkendelser af plantebeskyttelsesmidler, der indeholder ipconazol som aktivstof.
Decision 2008/20/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
Senest da skal medlemsstaterne navnlig kontrollere, at betingelserne i bilag I til nærværende forordning er overholdt, dog ikke betingelserne i kolonnen vedrørende særlige bestemmelser i samme bilag, og at indehaveren af godkendelsen er i besiddelse af eller har adgang til et dossier, der opfylder kravene i bilag II til direktiv 91/414/EØF, jf. betingelserne i direktivets artikel 13, stk. 1-4, samt artikel 62 i forordning (EF) nr. 1107/2009.
For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant.
Uanset stk. 1 revurderer medlemsstaterne for hvert godkendt plantebeskyttelsesmiddel, der indeholder ipconazol, enten som eneste aktivstof eller som ét af flere aktivstoffer, som alle er optaget i bilaget til gennemførelsesforordning (EU) nr. 540/2011 senest den 31. august 2014, midlet i overensstemmelse med de ensartede principper i artikel 29, stk. 6, i forordning (EF) nr. 1107/2009 på grundlag af et dossier, der opfylder kravene i bilag III til direktiv 91/414/EØF, idet der samtidig tages højde for kolonnen vedrørende særlige bestemmelser i bilag I til nærværende forordning.
The designated rapporteur Member State, the United Kingdom, submitted a draft assessment report on 22 May 2008.
På grundlag af den vurdering fastslår medlemsstaterne, om midlet opfylder kravene i artikel 29, stk. 1, i forordning (EF) nr. 1107/2009.
In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 [4] additional information was requested from the applicant on 20 May 2011.
Derefter skal medlemsstaterne:
The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report in November 2011.
hvis det drejer sig om et middel, der indeholder ipconazol som ét af flere aktivstoffer, om nødvendigt ændre eller tilbagekalde godkendelsen senest den 29. februar 2016 eller senest den dato, der er fastsat for en sådan ændring eller tilbagekaldelse i den eller de pågældende retsakter, hvorved det eller de pågældende stoffer blev optaget i bilag I til direktiv 91/414/EØF, eller hvorved det eller de pågældende stoffer blev godkendt, alt efter hvilket der er det seneste tidspunkt.
The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’).
Artikel 3
The Authority presented to the Commission its conclusion [5] on the peer review of the pesticide risk assessment of the active substance ipconazole on 2 April 2013.
Ændring af gennemførelsesforordning (EU) nr. 540/2011
The draft assessment 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 20 March 2014 in the format of the Commission review report for ipconazole.
Bilaget til gennemførelsesforordning (EU) nr. 540/2011 ændres som angivet i bilag II til nærværende forordning.
It has appeared from the various examinations made that plant protection products containing ipconazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report.
Artikel 4
It is therefore appropriate to approve ipconazole.
Ikrafttrædelse og anvendelsesdato
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende.
It is, in particular, appropriate to require further confirmatory information.
Den anvendes fra den 1. september 2014.
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
EUT L 309 af 24.11.2009, s. 1.
Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply.
Rådets direktiv 91/414/EØF af 15. juli 1991 om markedsføring af plantebeskyttelsesmidler (EFT L 230 af 19.8.1991, s. 1).
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing ipconazole.
Kommissionens beslutning 2008/20/EF af 20. december 2007 om principiel anerkendelse af, at de dossierer, der er fremlagt til detaljeret gennemgang med henblik på eventuel optagelse af ipconazol og maltodextrin i bilag I til Rådets direktiv 91/414/EØF, er komplet (EUT L 1 af 4.1.2008, s. 5).
Member States should, as appropriate, vary, replace or withdraw authorisations.
Kommissionens forordning (EU) nr. 188/2011 af 25. februar 2011 om gennemførelsesbestemmelser til Rådets direktiv 91/414/EØF for så vidt angår proceduren for vurdering af aktivstoffer, der ikke fandtes på markedet to år efter meddelelsen af direktivet (EUT L 53 af 26.2.2011, s. 51).
By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.
Den Europæiske Fødevaresikkerhedsautoritet:
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 [6] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
EFSA Journal 2013;11(4):3181.
In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive.
Foreligger online:
However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.
Kommissionens forordning (EØF) nr. 3600/92 af 11. december 1992 om de nærmere bestemmelser for iværksættelsen af første fase af det arbejdsprogram, der er omhandlet i artikel 8, stk. 2, i Rådets direktiv 91/414/EØF om markedsføring af plantebeskyttelsesmidler (EFT L 366 af 15.12.1992, s. 10).
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 [7] should be amended accordingly.
Kommissionens gennemførelsesforordning (EU) nr. 540/2011 af 25. maj 2011 om gennemførelse af Europa-Parlamentets og Rådets forordning (EF) nr. 1107/2009 for så vidt angår listen over godkendte aktivstoffer (EUT L 153 af 11.6.2011, s. 1).
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Almindeligt anvendt navn, identifikationsnr.
The active substance ipconazole, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
IUPAC-navn
Re-evaluation of plant protection products
Renhed [1]
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing ipconazole as an active substance by 28 February 2015.
Godkendelsesdato
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
Udløbsdato for stoffets godkendelse
By way of derogation from paragraph 1, for each authorised plant protection product containing ipconazole as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 August 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation.
Særlige bestemmelser
On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
Ipconazol
Following that determination Member States shall:
CAS-nr.:
in the case of a product containing ipconazole as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2016 at the latest;
125225-28-7 (blanding af diastereoisomerer)
in the case of a product containing ipconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.
115850-69-6 (ipconazol cc, cisisomer)
Article 3
115937-89-8 (ipconazol ct, transisomer) CIPAC-nr.:
Amendments to Implementing Regulation (EU) No 540/2011
Ipconazol cc:
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
875930 g/kg
Article 4
65-95 g/kg
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
31. august 2024
OJ L 309, 24.11.2009, p. 1.
Ved gennemførelsen af de i artikel 29, stk. 6, i forordning (EF) nr. 1107/2009 nævnte ensartede principper skal der tages hensyn til konklusionerne i den reviderede vurderingsrapport om ipconazol, særlig tillæg I og II, som færdigbehandlet i Den Stående Komité for Fødevarekæden og Dyresundhed den 20. marts 2014.
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
Ved denne samlede vurdering skal medlemsstaterne være særligt opmærksomme på:
Commission Decision 2008/20/EC of 20 December 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of ipconazole and maltodextrin in Annex I to Council Directive 91/414/EEC (OJ L 1, 4.1.2008, p. 5).
risikoen for frøædende fugle
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).
beskyttelsen af arbejdstagere og brugere
European Food Safety Authority;
risikoen for fisk.
Conclusion on the peer review of the pesticide risk assessment of the active substance ipconazole.
Anvendelsesbetingelserne skal omfatte risikobegrænsende foranstaltninger, hvis det er relevant.
EFSA Journal 2013;11(4):3181.
Ansøgeren fremlægger bekræftende oplysninger om:
[76 pp.] doi:10.2903/j.efsa.2013.3181.
hvorvidt risikoen på lang sigt for frøædende fugle er acceptabel
Available online:
hvorvidt risikoen for makroorganismer i jorden er acceptabel
Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 366, 15.12.1992, p. 10).
risikoen for enantioselektiv metabolisering eller nedbrydning
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
ipconazols potentielle hormonforstyrrende egenskaber med virkninger for fugle og fisk.
ANNEX I
Ansøgeren forelægger Kommissionen, medlemsstaterne og autoriteten oplysningerne i litra a) og b) senest den 31. august 2016, oplysningerne i litra c) senest to år efter vedtagelsen af de relevante retningslinjer for evaluering af isomerblandinger og oplysningerne i litra d) senest to år efter vedtagelsen af OECD's retningslinjer for testning af hormonforstyrrende stoffer eller alternativt efter vedtagelsen af retningslinjer for testning på EU-plan.
Common Name, Identification Numbers
Yderligere oplysninger om aktivstoffets identitet og specifikation fremgår af den reviderede vurderingsrapport.
IUPAC Name
BILAG II
Purity [1]
Ansøgeren forelægger Kommissionen, medlemsstaterne og autoriteten oplysningerne i litra a) og b) senest den 31. august 2016, oplysningerne i litra c) senest to år efter vedtagelsen af de relevante retningslinjer for evaluering af isomerblandinger og oplysningerne i litra d) senest to år efter vedtagelsen af OECD's retningslinjer for testning af hormonforstyrrende stoffer eller alternativt efter vedtagelsen af retningslinjer for testning på EU-plan.«
Specific provisions
I henhold til artikel 80, stk. 1, litra a), i forordning (EF) nr. 1107/2009 finder Rådets direktiv 91/414/EØF [2], for så vidt angår godkendelsesprocedure og -betingelser, anvendelse på aktivstoffer, for hvilke der inden den 14. juni 2011 er truffet en afgørelse i overensstemmelse med direktivets artikel 6, stk. 3.
Ipconazole
Med hensyn til ipconazol er betingelserne i artikel 80, stk. 1, litra a), i forordning (EF) nr. 1107/2009 opfyldt ved Kommissionens beslutning 2008/20/EF [3].
CAS No
www.efsa.europa.eu/efsajournal.
125225-28-7 (mixture of diastereoisomers)
hvis det drejer sig om et middel, der indeholder ipconazol som eneste aktivstof, om nødvendigt ændre godkendelsen eller trække den tilbage senest den 29. februar 2016, eller
115850-69-6 (ipconazole cc, cis isomer)
Kommissionens gennemførelsesforordning (EU) nr. 572/2014
Commission Implementing Regulation (EU) No 572/2014
Kommissionens delegerede forordning (EU) nr. 574/2014
Commission Delegated Regulation (EU) No 574/2014
om ændring af bilag III til Europa-Parlamentets og Rådets forordning (EU) nr. 305/2011 for så vidt angår den model, der skal anvendes til udarbejdelse af ydeevnedeklarationer for byggevarer
amending Annex III to Regulation (EU) No 305/2011 of the European Parliament and of the Council on the model to be used for drawing up a declaration of performance on construction products
Ydeevnedeklarationen udarbejdes i henhold til artikel 6, stk. 4, i forordning (EU) nr. 305/2011 ved hjælp af modellen i bilag III til forordningen.
According to Article 6(4) of Regulation (EU) No 305/2011, that declaration should be drawn up using the model set out in Annex III to that Regulation.
I henhold til artikel 60, litra e), i forordning (EU) nr. 305/2011 delegeres Kommissionen beføjelse til at tilpasse bilag III til forordning (EU) nr. 305/2011 for at tage hensyn til den tekniske udvikling.
In accordance with Article 60(e) of Regulation (EU) No 305/2011, the Commission is delegated the task of adapting Annex III to Regulation (EU) No 305/2011 in response to technical progress.
Modellen i bilag III til forordning (EU) nr. 305/2011 bør tilpasses for at tage hensyn til den tekniske udvikling, for at tilvejebringe den fleksibilitet, der er nødvendig for visse typer byggevarer og for fabrikanterne, samt for at forenkle ydeevnedeklarationen.
The model set out in Annex III to Regulation (EU) No 305/2011 should be adapted, in order to respond to technological progress, to allow the flexibility required by different kinds of construction products and manufacturers as well as to simplify the declaration of performance.
Desuden viser praktisk erfaring med gennemførelsen af bilag III, at fabrikanterne behøver yderligere retningslinjer om udarbejdelsen af ydeevnedeklarationer for byggevarer i overensstemmelse med gældende lovgivning.
Furthermore, practical experience with the implementation of Annex III shows that manufacturers would need further instructions for drawing up declarations of performance on construction products in line with applicable legislation.
Denne vejledning vil også sikre en ensartet og korrekt anvendelse af bilag III.
Providing such instructions would also ensure a harmonised and correct application of Annex III.
Fabrikanterne bør indrømmes en vis fleksibilitet med henblik på udarbejdelsen af ydeevnedeklarationer, forudsat at de klart og sammenhængende formidler de væsentlige oplysninger, der kræves i henhold til artikel 6 i forordning (EU) nr. 305/2011.
The manufacturers should be allowed some flexibility for drawing up declarations of performance as long as they provide, in a clear and coherent manner, the essential information required by Article 6 of Regulation (EU) No 305/2011.
For utvetydigt at identificere den vare, der er omfattet af en deklaration med hensyn til dets ydeevneniveauer eller -klasser bør producenterne kæde hver enkelt vare sammen med den respektive varetype og et givet sæt ydeevneniveauer eller -klasser ved hjælp af den unikke identifikationskode, der er omhandlet i artikel 6, stk. 2, litra a), i forordning (EU) nr. 305/2011.
In order to unequivocally identify the product covered by a declaration of performance in relation with its performance levels or classes, manufacturers should link every single product to the respective product-type and to a given set of performance levels or classes by the unique identification code referred to in Article 6(2)(a) of Regulation (EU) No 305/2011.
Formålet med artikel 11, stk. 4, i forordning (EU) nr. 305/2011 er, at alle byggevarer skal kunne identificeres og spores, og fabrikanterne skal derfor angive et type-, parti- eller serienummer.
The purpose of Article 11(4) of Regulation (EU) No 305/2011 is to enable the identification and the traceability of any single construction product by the indication, by the manufacturers, of a type, batch or serial number.
Dette formål opfyldes ikke med en ydeevnedeklaration, som efterfølgende bør anvendes til alle varer, der svarer til den varetype, der er defineret heri.
This purpose is not served by a declaration of performance, which should be subsequently used for all products corresponding to the product-type defined in it.
Derfor bør disse oplysninger, jf. artikel 11, stk. 4, ikke indgå i ydeevnedeklarationen.
Therefore, the information required by Article 11(4) should not be required to be contained in the declaration of performance.
Når de notificerede organer er korrekt identificeret, kan medtagelsen af alle attester eller prøvnings-, beregnings- eller vurderingsrapporter blive omfattende og byrdefuld, men den skaber ikke merværdi for brugerne af de varer, der er omfattet af en ydeevnedeklaration.
When the notified bodies are properly identified, the listing of all certificates, test, calculation or assessment reports issued might become extensive and burdensome but does not bring about added value for the users of the products covered by a declaration of performance.
Fabrikanterne bør derfor ikke være forpligtet til at medtage disse oplysninger i deres ydeevnedeklarationer.
The manufacturers should thus not be obliged to include these listings in their declarations of performance.
For at øge hele den europæiske byggesektors effektivitet og konkurrenceevne bør fabrikanter, som tilvejebringer ydeevnedeklarationer, og som ønsker at anvende forenklingen og vejledningen for at lette tilvejebringelsen af sådanne deklarationer, have mulighed for at gøre dette så hurtigt som muligt —
In order to enhance the efficiency and competitiveness of the European construction sector as a whole, manufacturers providing declarations of performance wishing to benefit from the simplification and instructions for the purposes of facilitating the provision of such declarations should be able to do so as soon as possible,
Bilag III til forordning (EU) nr. 305/2011 erstattes af bilaget til nærværende forordning.
Annex III to Regulation (EU) No 305/2011 shall be replaced by the Annex to this Regulation.
Ydeevnedeklarationer, som er udstedt før denne forordnings ikrafttrædelse, og som er i overensstemmelse med artikel 6 i forordning (EU) nr. 305/2011 og det oprindelige bilag III til samme forordning, anses for at være i overensstemmelse med nærværende forordning.
Declarations of performance issued before the entry into force of this Regulation, which comply with Article 6 of Regulation (EU) No 305/2011 and the initial Annex III thereto, shall be deemed to comply with this Regulation.
Varetypens unikke identifikationskode:
Unique identification code of the product-type:
Tilsigtet anvendelse:
Intended use/es:
Bemyndiget repræsentant:
Authorised representative:
System eller systemer til vurdering og kontrol af konstansen af ydeevnen:
System/s of AVCP:
Harmoniseret standard:
Harmonised standard:
Notificeret organ/notificerede organer:
Notified body/ies:
Europæisk vurderingsdokument:
European Assessment Document:
Europæisk teknisk vurdering:
European Technical Assessment:
Teknisk vurderingsorgan:
Technical Assessment Body:
Deklareret ydeevne/deklarerede ydeevner:
Declared performance/s:
Relevant teknisk dokumentation og/eller specifik teknisk dokumentation:
Appropriate Technical Documentation and/or Specific Technical Documentation:
Ydeevnen for den vare, der er anført ovenfor, er i overensstemmelse med den deklarerede ydeevne.
The performance of the product identified above is in conformity with the set of declared performance/s.
Denne ydeevnedeklaration er udarbejdet i overensstemmelse med forordning (EU) nr. 305/2011 på eneansvar af den fabrikant, der er anført ovenfor.
This declaration of performance is issued, in accordance with Regulation (EU) No 305/2011, under the sole responsibility of the manufacturer identified above.
[Sted] [dato] den
At [place] on [date of issue]
[Underskrift]
[signature]