natgillin/translations-raw huggingface dataset:
in the case of a product containing 6-Benzyladenine as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje 6-benziladenin kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo, ali
in the case of a product containing 6-Benzyladenine as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje 6-benziladenin kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za takšno spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
This Directive shall enter into force on 1 June 2011.
Ta direktiva začne veljati 1. junija 2011.
Done at Brussels, 3 January 2011.
V Bruslju, 3. januarja 2011
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 6-benzyladenine.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo 6-benziladenin.
Available online: www.efsa.europa.eu.
Na voljo na spletu: www.efsa.europa.eu.
CIPAC No 829
Št. CIPAC: 829
1 June 2011
1. junija 2011
31 May 2021
31. maja 2021
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 6-Benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za 6-benziladenin ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 23. novembra 2010.
In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.
V tej celoviti oceni morajo biti države članice zlasti pozorne na zaščito vodnih organizmov.
Risk mitigation measures such as buffer zones shall be applied, where appropriate.’
Kadar je primerno, je treba izvajati ukrepe za zmanjšanje tveganja, kot so varovalni pasovi.“
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing 6-Benzyladenine to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo 6-benziladenin, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13, in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
Decision 2008/941/EC provides for the non-inclusion of 6-Benzyladenine and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011.
Odločba 2008/941/ES določa nevključitev 6-benziladenina in preklic registracije fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning 6-Benzyladenine in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico, ki zadeva 6-benziladenin.
EFSA Journal 2010; 8(10):1716. [49 pp.]. doi:10.2903/j.efsa.2010.1716.
EFSA Journal 2010; 8(10):1716 [49 pp.]. doi:10.2903/j.efsa.2010.1716.
Commission Directive 2011/2/EU
Direktiva Komisije 2011/2/EU
amending Council Directive 91/414/EEC to include myclobutanil as active substance and amending Decision 2008/934/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve miklobutanila kot aktivne snovi in o spremembi Odločbe 2008/934/ES
That list included myclobutanil.
Navedeni seznam je vključeval miklobutanil.
In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report.
V skladu s členom 11e Uredbe (ES) št. 1490/2002 je prijavitelj umaknil svoj predlog za vključitev navedene aktivne snovi v Prilogo I k Direktivi 91/414/EGS v dveh mesecih po prejemu osnutka poročila o presoji iz člena.
Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of myclobutanil.
Zato je bila v zvezi z nevključitvijo miklobutanila sprejeta Odločba Komisije 2008/934/ES z dne 5. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo te snovi [4].
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Article 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [5].
Prvotni prijavitelj (v nadaljnjem besedilu: vložnik) je v skladu s členom 6(2) Direktive 91/414/EGS vložil nov zahtevek za uporabo pospešenega postopka iz členov 14 do 19 Uredbe Komisije (ES) št. 33/2008 z dne 17. januarja 2008 o podrobnih pravilih za izvajanje Direktive Sveta 91/414/EGS glede rednega in pospešenega postopka za oceno aktivnih snovi, ki so bile del programa dela iz člena 8(2) navedene direktive, vendar niso bile vključene v Prilogo I [5].
The application was submitted to Belgium, which had been designated rapporteur Member State by Regulation (EC) No 451/2000.
Zahtevek je bil predložen Belgiji, ki je bila z Uredbo (ES) št. 451/2000 imenovana za državo članico poročevalko.
Belgium evaluated the additional data submitted by the applicant and prepared an additional report.
Belgija je ocenila dodatne podatke, ki jih je predložil vložnik, in pripravila dodatno poročilo.
It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 22 October 2009.
Navedeno poročilo je 22. oktobra 2009 predložila Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) in Komisiji.
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 myclobutanil to the Commission on 11 July 2010 [6].
V skladu s členom 20(1) Uredbe (ES) št. 33/2008 in na zahtevo Komisije je Agencija 11. julija 2010 Komisiji predstavila svoje sklepe o miklobutanilu [6].
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 23 November 2010 in the format of the Commission review report for myclobutanil.
Osnutek poročila o oceni, dodatno poročilo in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 23. novembra 2010 v obliki poročila Komisije o pregledu glede miklobutanila.
It has appeared from the various examinations made that plant protection products containing myclobutanil may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo miklobutanil, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) Direktive 91/414/EGS, zlasti v zvezi z uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include myclobutanil in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti miklobutanil v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
Therefore, it is appropriate to require that the applicant submit further information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.
Zato je primerno zahtevati, da vložnik predloži dodatne informacije o ostankih miklobutanila in njegovih metabolitov v naslednjih rastnih dobah ter informacije, ki potrjujejo, da razpoložljivi podatki o ostankih zajemajo vse spojine iz opredelitve ostanka.
Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing myclobutanil to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC.
Brez poseganja v obveznosti iz Direktive 91/414/EGS, ki izhajajo iz vključitve aktivne snovi v Prilogo I, je državam članicam treba omogočiti, da v šestih mesecih po vključitvi snovi pregledajo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo miklobutanil, da zagotovijo izpolnjevanje zahtev iz Direktive 91/414/EGS, zlasti iz člena 13 in ustreznih pogojev iz Priloge I. Države članice v skladu z določbami Direktive 91/414/EGS obstoječe registracije po potrebi spremenijo, nadomestijo ali prekličejo.
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.
Vendar ta razjasnitev državam članicam ali imetnikom registracij ne nalaga nikakršnih novih obveznosti v primerjavi z doslej sprejetimi direktivami o spremembah Priloge I.
It is therefore appropriate to amend Decision 2008/934/EC accordingly.
Odločbo 2008/934/ES je zato treba ustrezno spremeniti.
The line concerning myclobutanil in the Annex to Decision 2008/934/EC is deleted.
V Prilogi k Odločbi 2008/934/ES se črta vrstica, ki zadeva miklobutanil.
Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 30. novembra 2011 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing myclobutanil as an active substance by 30 November 2011.
Države članice v skladu z Direktivo 91/414/EGS do 30. novembra 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo miklobutanil kot aktivno snov.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to myclobutanil are met, with the exception of those identified in Part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k navedeni direktivi v zvezi z miklobutanilom, z izjemo tistih iz dela B besedila o navedeni aktivni snovi, izpolnjeni in ali ima imetnik registracije dokumentacijo ali dostop do dokumentacije, ki izpolnjuje zahteve iz Priloge II k navedeni direktivi v skladu s pogoji iz člena 13 navedene direktive.
By way of derogation from paragraph 1, for each authorised plant protection product containing myclobutanil as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account Part B of the entry in Annex I to that Directive concerning myclobutanil.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje miklobutanil kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. maja 2011, v skladu z enotnimi načeli iz Priloge VI k Direktivi 91/414/EGS na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k navedeni direktivi, in ob upoštevanju dela B besedila o miklobutanilu iz Priloge I k navedeni direktivi.
in the case of a product containing myclobutanil as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or
če sredstvo vsebuje miklobutanil kot edino aktivno snov, najpozneje do 31. maja 2015 po potrebi spremenijo ali prekličejo registracijo ali
in the case of a product containing myclobutanil as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
če sredstvo vsebuje miklobutanil kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. maja 2015 ali do datuma, določenega za takšno spremembo ali preklic v ustreznih direktivah, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
European Food Safety Authority — ‘Conclusion on the peer review of the pesticide risk assessment of the active substance myclobutanil’, EFSA Journal 2010 8(10) 1682 [83pp]. doi: 10.2903/jefsa.2010.1682.
[6] Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo miklobutanil. EFSA Journal 2010 8(10) 1682 [83pp]. doi: 10.2903/jefsa.2010.1682.
Available online: www.efsa.europa.eu/efsajournal.htm
Na voljo na spletu: www.efsa.europa.eu/efsajournal.htm
CAS No: 88671-89-0
Št. CAS: 88671-89-0
CIPAC No: 442
Št. CIPAC: 442
1 June 2011
Čistost 1-metilpirolidin-2-ona ne presega 1g/kg v tehničnem materialu. 1. junija 2011
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on myclobutanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za miklobutanil ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 23. novembra 2010.
In this overall assessment Member States shall pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate.
V celoviti oceni morajo biti države članice zlasti pozorne na varnost izvajalca in zagotoviti, da je v pogojih uporabe po potrebi predpisana uporaba ustrezne osebne zaščitne opreme.
The Member States concerned shall request the submission of confirmatory information on the residues of myclobutanil and its metabolites in following growing seasons and information confirming that the available residue data cover all compounds of the residue definition.
Zadevne države članice zahtevajo predložitev potrditvenih informacij o ostankih miklobutanila in njegovih metabolitov v naslednjih rastnih dobah ter informacij, ki potrjujejo, da razpoložljivi podatki o ostankih zajemajo vse spojine iz opredelitve ostanka.
The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 January 2013.’
Zadevne države članice zagotovijo, da vložnik Komisiji do 31. januarja 2013 predloži potrditvene informacije.“
Decision 2008/934/EC provides for the non-inclusion of myclobutanil and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011.
Odločba 2008/934/ES določa nevključitev miklobutanila in preklic registracij fitofarmacevtskih sredstev, ki vsebujejo navedeno snov, do 31. decembra 2011.
It is necessary to delete the line concerning myclobutanil in the Annex to that Decision.
V Prilogi k navedeni odločbi je treba črtati vrstico, ki zadeva miklobutanil.
≥ 925 g/kg The impurity 1-methylpyrrolidin-2-one shall not exceed 1g/kg in the technical material
≥ 925 g/kg
Commission Directive 2011/3/EU
Direktiva Komisije 2011/3/EU
of 17 January 2011
z dne 17. januarja 2011
amending Directive 2008/128/EC laying down specific purity criteria on colours for use in foodstuffs
o spremembi Direktive 2008/128/ES o določitvi posebnih meril čistosti v zvezi z barvili za uporabo v živilih
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives [1], and in particular Article 30(5) thereof,
ob upoštevanju Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila [1] in zlasti člena 30(5) Uredbe,
Commission Directive 2008/128/EC [2] sets out the specific purity criteria concerning colours for use in foodstuffs, which colours are mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs [3].
Direktiva Komisije 2008/128/ES [2] določa posebna merila čistosti v zvezi z barvili za uporabo v živilih, ki so navedena v Direktivi Evropskega parlamenta in Sveta 94/36/ES z dne 30. junija 1994 o barvilih za uporabo v živilih [3].
Under Article 30(4) of Regulation (EC) No 1333/2008 specifications of the food additives covered under paragraphs 1 to 3 of that Article (which include also additives authorised under Directive 94/36/EC) shall be adopted, in accordance with Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [4], at the moment those food additives are entered in the Annexes in accordance with those paragraphs.
Člen 30(4) Uredbe (ES) št. 1333/2008 z dne 16. decembra 2008 določa, da se specifikacije aditivov za živila iz odstavkov 1 do 3 navedenega člena (ki vključujejo tudi aditive, odobrene z Direktivo 94/36/ES) sprejmejo v skladu z Uredbo (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila [4] takoj, ko se ti aditivi za živila vključijo v priloge v skladu z navedenimi odstavki.
Since the lists have not yet been drawn up, and in order to ensure that the modification of the Annexes to Directive 94/36/EC pursuant to Article 31 of Regulation (EC) No 1333/2008 is effective and that additives so authorised comply with safe conditions of use, Directive 2008/128/EC should therefore be amended.
Direktivo 2008/128/ES je treba spremeniti, ker seznami še niso pripravljeni ter za zagotovitev veljavnosti sprememb v prilogah k Direktivi 94/36/ES v skladu s členom 31 Uredbe (ES) št. 1333/2008 in usklajenosti aditivov, odobrenih na ta način, z varnimi pogoji uporabe.
The European Food Safety Authority (hereinafter ‘the Authority’) has assessed the information on the safety in use of lycopene as a food colour from all sources in its opinion of 30 January 2008 [5].
(4) Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 30. januarja 2008 [5] ocenila podatke o varnosti uporabe likopena kot živilskega barvila iz vseh virov.
The sources that were considered were the following: (a) E160d Lycopene obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent, (b) synthetic lycopene and (c) lycopene from Blakeslea trispora.
Upoštevani so bili naslednji viri: a) E 160d likopen, pridobljen z ekstrakcijo naravnih vlaken rdečih paradižnikov (Lycopersicon esculentum L.) s poznejšo odstranitvijo topila, b) sintetični likopen in c) likopen iz glive Blakeslea trispora.
Current legislation lays down specifications only for lycopene of red tomatoes and needs to be modified respectively by including the other two sources.
Trenutna zakonodaja določa specifikacije le za likopen iz rdečih paradižnikov in jo je treba spremeniti, da bo vsebovala tudi druga dva vira.
Specifications of lycopene extracted from red tomatoes need also to be updated.
Specifikacije za likopen, pridobljen z ekstrakcijo rdečega paradižnika, je tudi treba posodobiti.
Dichloromethane does not need to be listed in the list of the extraction solvents, as it is not used any more for lycopene of red tomatoes, according to the information received from stakeholders.
Diklorometana ni treba navesti na seznamu ekstrakcijskih topil, saj se glede na informacije zainteresiranih strani ne uporablja več za likopen iz rdečih paradižnikov.
Maximum limit for lead needs to be lowered due to safety reasons, and the reference on heavy metals is too generic and not relevant any more.
Zaradi varnostnih razlogov je treba zmanjšati mejno vrednost za svinec, navedba o težkih kovinah pa je preveč splošna in zato ni več ustrezna.
In addition the reference on natural strains needs to be updated according to Regulation (EC) No 1829/2003 of the European Parliament and of the Council [6].
Poleg tega je treba navedbo o naravnih vlaknih posodobiti v skladu z Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta [6].
Dichloromethane (methylene chloride) is being reported to be used for manufacturing ready-to-sale formulations of lycopene, mentioned also in the Authority's opinion on Safety of ‘Lycopene Cold Water Dispersible Products from Blakeslea trispora’ of 4 December 2008 [7].
Poročila za diklorometan (metilen klorid) navajajo, da se uporablja za proizvajanje formulacij likopena, pripravljenih za prodajo, kar je navedeno tudi v mnenju Agencije z dne 4. decembra 2008 [7] v zvezi z varnostjo izdelkov iz likopena, pridobljenega iz glive Blakeslea trispora z disperzijo v hladni vodi.
Similar products are produced also from synthetic lycopene, as mentioned in the Authority ' s opinion on safety of Synthetic Lycopene of 10 April 2008 [8].
Podobni izdelki se proizvajajo tudi iz sintetičnega likopena, kot je navedeno v mnenju Agencije o varnosti sintetičnega likopena z dne 10. aprila 2008 [8].