natgillin/translations-raw huggingface dataset:
Decision 2006/586/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.
Imenovana država članica poročevalka je 19. marca 2012 predložila osnutek poročila o oceni.
The designated rapporteur Member State submitted a draft assessment report on 19 March 2012.
Agencija je 31. oktobra 2013 Komisiji predložila sklep o oceni tveganja pesticidov z aktivno snovjo kromafenozid [4].
The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’).
Osnutek poročila o oceni in sklep Agencije so države članice in Komisija pregledale v okviru Stalnega odbora za rastline, živali, hrano in krmo ter končno različico pripravile 10. oktobra 2014 v obliki poročila Komisije o pregledu kromafenozida.
The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance chromafenozide [4] on 31 October 2013.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo kromafenozid, lahko pričakuje, da na splošno izpolnjujejo zahteve iz člena 5(1)(a) in (b) ter člena 5(3) Direktive 91/414/EGS, zlasti v zvezi z vrstami uporabe, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 10 October 2014 in the format of the Commission review report for chromafenozide.
Zato je primerno, da se kromafenozid odobri.
It has appeared from the various examinations made that plant protection products containing chromafenozide 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.
V skladu s členom 13(2) Uredbe (ES) št. 1107/2009 v povezavi s členom 6 Uredbe ter ob upoštevanju aktualnih znanstvenih in tehničnih dognanj pa je treba vključiti nekatere pogoje in omejitve.
It is therefore appropriate to approve chromafenozide.
Zlasti je primerno zahtevati dodatne potrditvene informacije.
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.
Državam članicam bi bilo treba po odobritvi omogočiti šestmesečno obdobje, da pregledajo registracije fitofarmacevtskih sredstev, ki vsebujejo kromafenozid.
Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing chromafenozide.
Z odstopanjem od navedenega roka bi bilo treba določiti daljše obdobje za predložitev in oceno celotne dokumentacije iz Priloge III za vsako fitofarmacevtsko sredstvo in za vsako nameravano uporabo po enotnih načelih iz Direktive 91/414/EGS.
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.
Prav tako je primerno, da se državam članicam omogoči podaljšanje veljavnosti začasnih registracij, izdanih za fitofarmacevtska sredstva, ki vsebujejo kromafenozid, da se jim zagotovi potreben čas za izpolnitev obveznosti iz te uredbe v zvezi z navedenimi začasnimi registracijami.
In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 [6] should be amended accordingly.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing chromafenozide in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.
SPREJELA NASLEDNJO UREDBO:
Article 1
Aktivna snov kromafenozid, kot je opredeljena v Prilogi I, se odobri v skladu s pogoji iz navedene priloge.
The active substance chromafenozide, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Ponovna ocena fitofarmacevtskih sredstev
Article 2
Države članice v skladu z Uredbo (ES) št. 1107/2009 do 30. septembra 2015 po potrebi spremenijo ali prekličejo veljavne registracije fitofarmacevtskih sredstev, ki vsebujejo kromafenozid kot aktivno snov.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing chromafenozide as an active substance by 30 September 2015.
Z odstopanjem od odstavka 1 države članice najpozneje do 31. marca 2015 znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje kromafenozid kot edino aktivno snov ali kot eno od aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, po enotnih načelih iz člena 29(6) Uredbe (ES) št. 1107/2009 na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju stolpca o posebnih določbah iz Priloge I k tej uredbi.
By way of derogation from paragraph 1, for each authorised plant protection product containing chromafenozide 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 March 2015 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.
Države članice nato:
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.
če sredstvo vsebuje kromafenozid kot eno od aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 30. septembra 2016 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
in the case of a product containing chromafenozide as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest;
Spremembe Izvedbene uredbe (EU) št. 540/2011
in the case of a product containing chromafenozide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 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.
Priloga k Izvedbeni uredbi (EU) št. 540/2011 se spremeni v skladu s Prilogo II k tej uredbi.
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Države članice lahko podaljšajo veljavnost začasnih registracij za fitofarmacevtska sredstva, ki vsebujejo kromafenozid, najpozneje do 30. septembra 2016.
Extension of existing provisional authorisations
Začetek veljavnosti in uporabe
Member States may extend existing provisional authorisations for plant protection products containing chromafenozide for a period ending on 30 September 2016 at the latest.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
It shall apply from 1 April 2015.
V Bruslju, 14. januarja 2015
Done at Brussels, 14 January 2015.
UL L 309, 24.11.2009, str. 1.
The President
Odločba Komisije 2006/586/ES z dne 25. avgusta 2006 o načelnem priznavanju popolnosti dokumentacije, predložene v podroben pregled zaradi možne vključitve kromafenozida, halosulfurona, tembotriona, valifenala in Zucchini yellow mosaic virus – šibkega seva v Prilogo I k Direktivi Sveta 91/414/EGS (UL L 236, 31.8.2006, str. 31).
OJ L 309, 24.11.2009, p. 1.
EFSA Journal 2013; 11(12):3461.
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).
Na voljo na spletu:
Commission Decision 2006/586/EC of 25 August 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chromafenozide, halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ L 236, 31.8.2006, p. 31).
Uredba Komisije (EGS) št. 3600/92 z dne 11. decembra 1992 o podrobnih pravilih za izvajanje prve faze delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet (UL L 366, 15.12.1992, str. 10).
EFSA Journal 2013;11(12):3461.
Izvedbena uredba Komisije (EU) št. 540/2011 z dne 25. maja 2011 o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede seznama registriranih aktivnih snovi (UL L 153, 11.6.2011, str. 1).
Available online:
PRILOGA I
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 (OJ L 366, 15.12.1992, p. 10).
Splošno ime, identifikacijska številka
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).
Ime po IUPAC
ANNEX I
Čistost [1]
Common Name, Identification Numbers
Datum odobritve
Purity [1]
Posebne določbe
Date of approval
Kromafenozid
Chromafenozide
št.
CIPAC No 775
Naslednja pomembna nečistoča ne sme presegati določene mejne vrednosti v tehničnem materialu:
The following relevant impurity must not exceed a certain threshold in the technical material:
Butil acetat (n-buthyl acetate, št.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu kromafenozida ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za rastline, živali, hrano in krmo pripravil 10. oktobra 2014.
the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;
tveganje za podtalnico, če se aktivna snov uporablja na območjih z občutljivimi tlemi ali neugodnimi podnebnimi razmerami;
the risk to non-target Lepidoptera in off-crop areas;
tveganje za neciljne metulje (red Lepidoptera) na nekmetijskih površinah;
the risk to sediment-dwelling organisms.
tveganje za organizme, ki živijo v usedlinah.
the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;
nepomembnosti razlike med materiali, ki se uporabljajo pri ekotoksikološkem preskušanju, in specifikacijo tehničnega materiala, ki je bila dogovorjena za oceno tveganja;
the assessment of the risk to sediment dwelling organisms from metabolite M-010;
oceni tveganja za organizme, ki živijo v usedlinah, kar se tiče metabolita M-010;
the leaching potential of metabolites M-006 and M-023 to groundwater.
možnosti izpiranja metabolitov M-006 in M-023 v podtalnico.
The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.
Vložnik Komisiji, državam članicam in Agenciji predloži ustrezne informacije iz točke 1 do 30. septembra 2015, iz točk 2 in 3 pa do 31. marca 2017.
Further details on identity and specification of active substance are provided in the review report.
Več podrobnosti o aktivni snovi in njenih lastnostih je na voljo v poročilu o pregledu.
Number
Vložnik Komisiji, državam članicam in Agenciji predloži ustrezne informacije iz točke 1 do 30. septembra 2015, iz točk 2 in 3 pa do 31. marca 2017.“
The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.’
V skladu s členom 80(1)(a) Uredbe (ES) št. 1107/2009 ter ob upoštevanju postopka in pogojev za odobritev je treba Direktivo Sveta 91/414/EGS [2] uporabljati za aktivne snovi, v zvezi s katerimi je bila pred 14. junijem 2011 sprejeta odločitev v skladu s členom 6(3) navedene direktive.
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.
Odločba Komisije 2006/586/ES [3] je potrdila, da kromafenozid izpolnjuje pogoje iz člena 80(1)(a) Uredbe (ES) št. 1107/2009.
EFSA Journal 2013; 11(10):3434.
Identifikacijska številka dodatka
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
Funkcionalna skupina: pospeševalci prebavljivosti.
Category of zootechnical additives.
DSM Nutritional Products Ltd., ki ga zastopa DSM Nutritional Products Sp.
Functional group: digestibility enhancers.
alfa-amilaza
Additive composition
v trdni obliki: 160 KNU [1]/g;
Preparation of alpha-amylase produced by Bacillus licheniformis (DSM 21564) having a minimum activity of:
v tekoči obliki: 240 KNU/g.
solid form: 160 KNU [1]/g;
Lastnosti aktivne snovi
liquid form: 240 KNU/g.
alfa-amilaza ES 3.2.1.1, ki jo proizvaja Bacillus licheniformis (DSM 21564).
In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting.
Zaradi varnosti je treba med ravnanjem uporabljati zaščito za dihala ter zaščitna očala in rokavice.
For use up to the 14th week of lactation.
4. februar 2025
For safety: breathing protection glasses and gloves shall be used during handling.
1 KNU je količina encima, ki sprosti 6 mikromole p-nitrofenola na minuto iz 1,86 mM etiliden-G7-p-nitrofenil-maltoheptaozida pri pH 7,0 in 37 °C.
4 February 2025
Podrobnosti o analitskih metodah so na voljo na naslovu referenčnega laboratorija: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
Commission Implementing Regulation (EU) 2015/53
Izvedbena uredba Komisije (EU) 2015/53
of 15 January 2015
z dne 15. januarja 2015
amending, as regards the trade in species of wild fauna and flora, Regulation (EC) No 865/2006 laying down detailed rules concerning the implementation of Council Regulation (EC) No 338/97
o spremembi Uredbe (ES) št. 865/2006 o določitvi podrobnih pravil za izvajanje Uredbe Sveta (ES) št. 338/97 glede trgovine s prosto živečimi živalskimi in rastlinskimi vrstami
Having regard to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein [1], and in particular Article 19(2), (3) and (4) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 338/97 z dne 9. decembra 1996 o varstvu prosto živečih živalskih in rastlinskih vrst z zakonsko ureditvijo trgovine z njimi [1] ter zlasti člena 19(2), (3) in (4) Uredbe,
In order to implement certain Resolutions adopted at the sixteenth meeting of the Conference of the Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (3-14 March 2013), hereinafter ‘the Convention’, certain provisions should be amended and further provisions should be added to Commission Regulation (EC) No 865/2006 [2].
Za izvajanje nekaterih resolucij, sprejetih na šestnajstem zasedanju konference pogodbenic Konvencije o mednarodni trgovini z ogroženimi prosto živečimi živalskimi in rastlinskimi vrstami (CITES) (3.–14. marca 2013) (v nadaljnjem besedilu: Konvencija), bi bilo treba spremeniti nekatere določbe in dodati dodatne določbe k Uredbi Komisije (ES) št. 865/2006 [2].
In particular, in line with CITES Resolution Conf.
Zlasti je pomembno, da se v skladu z resolucijo konf.
, specific provisions designed to simplify the non-commercial cross-border movement of musical instruments should be inserted.
CITES 16.8 vnesejo posebne določbe za poenostavitev nekomercialnega čezmejnega prenosa glasbil.
Experience gained in the implementation of Regulation (EC) No 865/2006, in conjunction with Commission Implementing Regulation (EU) No 792/2012 [3], has shown that some provisions therein should be amended in order to ensure that the Regulation is implemented in a harmonised and efficient manner within the Union.
Izkušnje z izvajanjem Uredbe (ES) št. 865/2006 v povezavi z Izvedbeno uredbo Komisije (EU) št. 792/2012 [3] so pokazale, da je treba nekatere določbe Uredbe spremeniti, da bi se zagotovilo njeno usklajeno in učinkovito izvajanje v Uniji.
This is the case in particular in relation to the first introduction into the Union of hunting trophies of specimens of some species or populations listed in Annex B to Regulation (EC) No 338/97, for which there are concerns as to the sustainability of trade in hunting trophies or for which there are indications of significant illegal trade.
To velja zlasti za prvi vnos lovskih trofej osebkov nekaterih vrst ali populacij iz Priloge B k Uredbi (ES) št. 338/97 v Unijo, za katere obstajajo pomisleki glede trajnosti trgovine z lovskimi trofejami ali za katere obstajajo namigi o občutnem nezakonitem trgovanju.
In such cases, more stringent control of imports into the Union is necessary and the derogation set out in Article 7(3) of Regulation (EC) No 338/97 for personal and household effects should therefore not apply.
V takih primerih je potreben strožji nadzor uvoza v Unijo, odstopanje iz člena 7(3) Uredbe (ES) št. 338/97 za osebne in gospodinjske predmete pa se zato ne bi smelo uporabljati.
Experience in implementing Regulation (EC) No 865/2006 has also shown that it was necessary to clarify that import permits should not be issued by Member States in cases where, despite a request to this end, they do not obtain satisfactory information from the exporting or re-exporting country as to the legality of the specimens to be imported into the EU.
Izkušnje z izvajanjem Uredbe (ES) št. 865/2006 so prav tako pokazale, da je treba pojasniti, da države članice ne bi smele izdajati uvoznih dovoljenj v primerih, kadar navzlic zahtevku po informacijah glede zakonitosti osebkov, ki bodo uvoženi v EU, od države izvoza ali ponovnega izvoza ne prejmejo zadostnih tovrstnih informacij.
At the sixteenth meeting of the Conference of the Parties to the Convention, the standard references for nomenclature were updated.
Na šestnajstem zasedanju konference pogodbenic Konvencije so bili posodobljeni standardni viri.
These references are used to indicate scientific names of species in permits and certificates.
Ti viri se uporabljajo za navajanje znanstvenih imen vrst v dovoljenjih in potrdilih.
Those changes should be reflected in Annex VIII to Regulation (EC) No 865/2006.
Navedene spremembe bi se morale odražati v Prilogi VIII k Uredbi (ES) št. 865/2006.
Regulation (EC) No 865/2006 should be amended accordingly.
Uredbo (ES) št. 865/2006 bi bilo zato treba ustrezno spremeniti.
As this Regulation should be used in conjunction with Regulation (EU) No 792/2012, it is important that both Regulations apply as of the same day.
Ker bi bilo to uredbo treba uporabljati v povezavi z Izvedbeno uredbo (EU) št. 792/2012, je pomembno, da se obe uredbi začneta uporabljati na isti dan.
Regulation (EC) No 865/2006 is amended as follows:
Uredba (ES) št. 865/2006 se spremeni:
point (6) is replaced by the following:
‚potujoča razstava‘ pomeni zbirko vzorcev, cirkus, zverinjak, razstavo rastlin, orkester ali muzejsko razstavo, ki se uporablja za javno prikazovanje v komercialne namene;“
“travelling exhibition” means a sample collection, circus, menagerie, plant exhibition, orchestra or museums exhibition that is used for commercial display for the public;’
v členu 4(1) se drugi pododstavek nadomesti z naslednjim:
In Article 4(1), the second subparagraph is replaced by the following:
„Vendar se vloge za izdajo uvoznih in izvoznih dovoljenj, potrdil o ponovnem izvozu, potrdil iz členov 5(2)(b), 5(3), 5(4), 8(3) in 9(2)(b) Uredbe (ES) št. 338/97, potrdila o osebnem lastništvu, potrdila o zbirki vzorcev, potrdila o glasbilih in potrdila o potujočih razstavah, kakor tudi uradna obvestila o uvozu, dopolnilni listi in etikete, lahko izpolnijo ročno, vendar čitljivo, s črnilom in z velikimi tiskanimi črkami.“
‘However, applications for import and export permits, for re-export certificates, for the certificates provided for in Articles 5(2)(b), 5(3), 5(4), 8(3) and 9(2)(b) of Regulation (EC) No 338/97, for personal ownership certificates, for sample collection certificates, for musical instrument certificates and for travelling exhibition certificates as well as import notifications, continuation sheets and labels may be completed in manuscript, provided this is done legibly, in ink and in block capitals.’
v členu 7 se doda naslednji odstavek 6:
In Article 7, the following paragraph 6 is added:
Izvozna dovoljenja in potrdila o ponovnem izvozu, ki jih izdajo tretje države, se sprejmejo samo, kadar pristojni organ zadevne tretje države na zahtevo predloži zadostne informacije, da so bili osebki pridobljeni v skladu z zakonodajo o varstvu zadevnih osebkov.“
Export permits and re-export certificates issued by third countries shall be accepted only if the competent authority from the third country concerned provides, where requested to do so, satisfactory information that the specimens were obtained in accordance with the legislation on the protection of the species concerned.’
člen 9 se nadomesti z naslednjim:
Article 9 is replaced by the following:
„Člen 9
‘Article 9
Pošiljke osebkov
Shipments of specimens
Brez poseganja v člene 31, 38, 44b, 44i in 44p se za vsako pošiljko osebkov, poslanih skupaj kot del enega tovora, izda ločeno uvozno dovoljenje, uradno obvestilo o uvozu, izvozno dovoljenje ali potrdilo o ponovnem izvozu.“
Without prejudice to Articles 31, 38, 44b, 44i and 44p, a separate import permit, import notification, export permit or re-export certificate shall be issued for each shipment of specimens shipped together as part of one load.’
člen 10 se spremeni:
Article 10 is amended as follows:
naslov se nadomesti z naslednjim:
the title is replaced by the following:
„Veljavnost uvoznih in izvoznih dovoljenj, potrdil o ponovnem izvozu, potrdil o potujoči razstavi, potrdil o osebnem lastništvu, potrdil o zbirki vzorcev in potrdil o glasbilih“
‘Validity of import and export permits, re-export certificates, travelling exhibition certificates, personal ownership certificates, sample collection certificates and musical instrument certificates’
odstavek 3 se nadomesti z naslednjim:
paragraph 3 is replaced by the following:
Veljavnost potrdil o potujoči razstavi, potrdil o osebnem lastništvu in potrdil o glasbilih, izdanih skladno s členi 30, 37 oziroma 44h, ne sme presegati treh let.“
The period of validity of the travelling exhibition certificates, personal ownership certificates and musical instrument certificates issued in accordance with Articles 30, 37 and 44h respectively shall not exceed three years.’
odstavka 5 in 6 se nadomestita z naslednjim:
paragraphs 5 and 6 are replaced by the following:
Potrdila o potujoči razstavi, potrdila o osebnem lastništvu ali potrdila o glasbilih prenehajo veljati, če je bil osebek prodan, izgubljen, uničen ali ukraden, ali če se je lastništvo osebka preneslo kako drugače, ali pri živih osebkih, če je poginil, ušel ali bil izpuščen v naravo.