natgillin/translations-raw huggingface dataset:
Annex I to Directive 2008/60/EC is amended in accordance with the Annex to this Directive.
Priloga I k Direktivi 2008/60/ES se spremeni v skladu s Prilogo k tej direktivi.
Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the European Commission on neotame as a sweetener and flavour enhancer.
Mnenje Znanstvenega odbora o aditivih za živila, aromah, pomožnih tehnoloških sredstvih in materialih v stiku z živili na zahtevo Evropske komisije o neotamu kot sladilu in ojačevalcu arome.
The EFSA Journal (2007) 581, 1-43.
The EFSA Journal (2007) 581, str. 1–43.
In Annex I to Directive 2008/60/EC the following entry E 961 is inserted after the entry E 959:
V Prilogi I k Direktivi 2008/60/ES se za vnosom E 959 vnese naslednji vnos E 961:
N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester,
N-[N-(3,3-dimetilbutil)-L-α-aspartil]-L-fenilalanin 1-metil ester,
N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester
N(3,3-dimetilbutil)-L-aspartil-L-fenilalanin metil ester.
Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst.
Neotam se pridobiva z reakcijo pod tlakom vodika iz aspartama s 3,3-dimetilbutiraldehidom v metanolu v prisotnosti paladija/ogljikovega katalizatorja.
It is isolated and purified by filtration, where diatomaceous earth may be used.
Izolira se in očisti s filtracijo, kjer se lahko uporabi diatomejska zemlja.
After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried
Po odstranitvi z destilacijo se neotam spere z vodo, izolira s centrifugiranjem in na koncu osuši z vakuumom.
CAS No
Št. CAS:
N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester
N-[N-(3,3-dimetilbutil)-L-α-aspartil]-L-fenilalanin 1-metil ester
Molecular weight
Molska masa
white to off-white powder
bel do sivobel prah
Not less than 97,0 % on the dried basis
najmanj 97,0 %, računano na suho snov
4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate
4,75 % (w/w) pri 60 °C v vodi, topen v etanolu in etil acetatu
Not more than 5 % (Karl Fischer, sample size 25 ± 5 mg)
največ 5 % (Karl Fischer, velikost vzorca 25 ± 5mg)
5,0 – 7,0 (0,5 % aqueous solution)
5,0–7,0 (0,5 % vodne raztopine)
81 °C to 84 °C
81 °C do 84 °C
N-[(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine
N-[N-(3,3-dimetilbutil)-L-α-aspartil]-L-fenilalanin
Not more than 1,5 %
največ 1,5 %
Not more than 1 mg/kg’
največ 1 mg/kg“
The European Food Safety Authority (EFSA) assessed the information on the safety in use of neotame as a sweetener and flavour enhancer and expressed its opinion of 27 September 2007 [4].
Evropska agencija za varnost hrane (EFSA) je ocenila informacije o varnosti neotama kot sladila in ojačevalca arome ter 27. septembra 2007 izrazila svoje mnenje [4].
On the basis of the proposed uses, it has been considered appropriate to permit the use of this food additive.
Na podlagi predlaganih uporab se zdi primerno, da se dovoli uporaba tega aditiva za živila.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2011 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. marca 2011.
Commission Directive 2010/38/EU
Direktiva Komisije 2010/38/EU
amending Council Directive 91/414/EEC to include sulfuryl fluoride as active substance
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve sulfuril fluorida kot aktivne snovi
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 29 July 2002 an application from Dow AgroScience for the inclusion of the active substance sulfuryl fluoride in Annex I to Directive 91/414/EEC.
V skladu s členom 6(2) Direktive 91/414/EGS je Združeno kraljestvo 29. julija 2002 prejelo zahtevek družbe Dow AgroScience za vključitev sulfuril fluorida kot aktivne snovi v Prilogo I k Direktivi 91/414/EGS.
The rapporteur Member State submitted a draft assessment report on 29 October 2004.
Država članica poročevalka je 29. oktobra 2004 predložila osnutek poročila o oceni.
It has appeared from the various examinations made that plant protection products containing sulfuryl fluoride 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.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo sulfuril fluorid, 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 uporabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu.
It is therefore appropriate to include sulfuryl fluoride in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti sulfuril fluorid v Prilogo I k navedeni direktivi, da se v vseh državah članicah v skladu z določbami navedene direktive lahko registrirajo fitofarmacevtska sredstva, ki vsebujejo to aktivno snov.
It is appropriate, as regards sulfuryl fluoride, to require that the notifier submit further information on milling processing conditions necessary to ensure that residues of fluoride ion in cereals do not exceed the natural background levels, on tropospheric concentrations of sulfuryl fluoride and on estimates of sulfuryl fluoride atmospheric lifetime.
V zvezi s sulfuril fluoridom je primerno zahtevati, da prijavitelj predloži dodatne informacije o potrebnih pogojih za predelavo v mlinih, da ostanki fluoridnih ionov v žitu ne presežejo vrednosti naravnega ozadja, o koncentraciji sulfuril fluorida v troposferi in o ocenah življenjske dobe sulfuril fluorida v atmosferi.
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 provisional authorisations of plant protection products containing sulfuryl fluoride 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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 začasne registracije fitofarmacevtskih sredstev, ki vsebujejo sulfuril fluorid, 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 začasne registracije po potrebi spremenijo v dokončne registracije, jih nadomestijo ali prekličejo.
By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
Z odstopanjem od navedenega roka je treba določiti daljše obdobje za predložitev in oceno celotne dokumentacije iz Priloge III vsakega fitofarmacevtskega sredstva za vsako nameravano uporabo v skladu z enotnimi načeli iz Direktive 91/414/EGS.
By way of derogation from paragraph 1, for each authorised plant protection product containing sulfuryl fluoride 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 August 2010 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 sulfuryl fluoride.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje sulfuril fluorid kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 31. avgusta 2010, 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 sulfuril fluoridu iz Priloge I k navedeni direktivi.
in the case of a product containing sulfuryl fluoride as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2012 at the latest; or
če sredstvo vsebuje sulfuril fluorid kot edino aktivno snov, najpozneje do 29. februarja 2012 po potrebi spremenijo ali prekličejo registracijo ali
in the case of a product containing sulfuryl fluoride as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2012 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 sulfuril fluorid kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 29. februarja 2012 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.
[66 pp.], Conclusion on the peer review of the pesticide risk assessment of the active substance sulfuryl fluoride (finalised: 17 December 2009).
[66 pp.], Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo sulfuril fluorid (dokončano: 17. decembra 2009).
In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:
Na koncu preglednice v Prilogi I k Direktivi 91/414/EGS se doda naslednje besedilo:
CAS No 002699-79-8
Št. CAS 002699-79-8
CIPAC No 757
Št. CIPAC 757
31 October 2020
oktober 2020
Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures
Samo uporabe kot insekticid/nematicid (fumigant), ki ga profesionalni uporabniki uporabljajo v prostorih z možnostjo zatesnitve,
which are empty; or
ki so prazni ali
where conditions of use ensure that consumer exposure is acceptable;
katerih pogoji uporabe omogočajo sprejemljivo izpostavljenost potrošnikov,
may be authorised.
se lahko registrirajo.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za sulfuril fluorid ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 11. maja 2010.
the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that such products do not enter the food and feed chain,
tveganje, ki ga predstavlja anorganski fluorid zaradi onesnaženih izdelkov, na primer moke in otrobov, ki ostaneta v mlinskih strojih med zaplinjevanjem, ali žita, shranjenega v silosih v mlinu. Potrebni so ukrepi za zagotovitev, da taki izdelki ne vstopijo v prehranjevalno in krmno verigo,
the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration.
tveganje za izvajalce in delavce, ko na primer ponovno vstopijo v zaplinjene prostore po zračenju.
Measures are required to ensure that they wear self containing breathing apparatus or other appropriate personal protective equipment,
Potrebni so ukrepi za zagotovitev, da nosijo samostojne dihalne aparate ali drugo primerno osebno zaščitno opremo,
the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.
tveganje za mimoidoče, tako da vzpostavijo primerno območje izključitve okoli zaplinjenih prostorov.
The Member States concerned shall ensure that the notifier submits to the Commission further information and in particular, confirmatory data on:
Zadevne države članice zagotovijo, da prijavitelj Komisiji predloži dodatne informacije in zlasti potrdilne podatke o:
the mill processing conditions necessary to ensure that residues of fluoride ion in flour, bran and grain do not exceed the natural background levels,
potrebnih pogojih za predelavo v mlinih, da ostanki fluoridnih ionov v moki, otrobih in žitu ne presežejo vrednosti naravnega ozadja,
tropospheric concentrations of sulfuryl fluoride.
koncentraciji sulfuril fluorida v troposferi.
Measured concentrations should be updated regularly.
Meritve koncentracij je treba redno izvajati.
The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air),
Mejna vrednost odkritja za analizo je najmanj 0,5 ppt (kar ustreza 2,1 ng sulfuril fluorida/m3 troposferskega ozračja),
estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario, with respect to the global warming potential (GWP).
ocenah življenjske dobe sulfuril fluorida v atmosferi na podlagi najslabšega možnega scenarija glede na potencial segrevanja ozračja.
They shall ensure that the notifier provides such information to the Commission by 31 August 2012.’
Države članice zagotovijo, da prijavitelj Komisiji predloži takšne informacije do 31. avgusta 2012.“
Further details on identity and specification of active substances are provided in the review report.
Več podrobnosti o aktivnih snoveh in njihovih lastnostih so v poročilu o pregledu.
The assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) and presented to the Commission on 17 December 2009 [3].
Poročilo o oceni so pregledali strokovnjaki držav članic in Evropske agencije za varnost hrane (EFSA) ter ga 17. decembra 2009 [3] predložili Komisiji.
The draft review report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for sulfuryl fluoride.
Osnutek poročila o pregledu so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 12. marca 2010 v obliki poročila Komisije o pregledu glede sulfuril fluorida.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing sulfuryl fluoride as active substance by 28 February 2011.
Države članice v skladu z Direktivo 91/414/EGS do 28. februarja 2011 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo sulfuril fluorid kot aktivno snov.
By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to sulfuryl fluoride are met, with the exception of those identified in part B of the entry concerning the 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(2) of that Directive.
Do navedenega datuma zlasti preverijo, ali so pogoji iz Priloge I k navedeni direktivi v zvezi s sulfuril fluoridom, 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(2) navedene direktive.
Commission Directive 2010/39/EU
Direktiva Komisije 2010/39/EU
amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to the active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen
o spremembi Priloge I k Direktivi Sveta 91/414/EGS glede posebnih določb za aktivne snovi klofentezin, diflubenzuron, lenacil, oksadiazon, pikloram in piriproksifen
The active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen were included in Annex I to Directive 91/414/EEC by Commission Directive 2008/69/EC [2] in accordance with the procedure provided for in Article 11b of Commission Regulation (EC) No 1490/2002 [3].
Z Direktivo Komisije 2008/69/ES [2] so bile v skladu s postopkom iz člena 11b Uredbe Komisije (ES) št. 1490/2002 [3] v Prilogo I k Direktivi 91/414/EGS vključene aktivne snovi klofentezin, diflubenzuron, lenacil, oksadiazon, pikloram in piriproksifen.
Taking into account the EFSA conclusions, it is confirmed that plant protection products containing clofentezine, diflubenzuron, lenacil, oxadiazon, picloram or pyriproxyfen 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 were examined and detailed in the Commission review report.
Ob upoštevanju sklepov EFSA je potrjeno, da je za fitofarmacevtska sredstva, ki vsebujejo klofentezin, diflubenzuron, lenacil, oksadiazon, pikloram ali piriproksifen, mogoče pričakovati, 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.
For certain substances it is necessary to include specific provisions requiring Member States, when authorising those substances, to pay particular attention to certain points or to ensure that appropriate risk mitigation measures are taken.
Za nekatere snovi je treba vključiti posebne določbe, da morajo biti države članice pri odobritvi navedenih snovi zlasti pozorne na nekatere točke ali morajo zagotoviti, da so sprejeti ustrezni ukrepi za zmanjšanje tveganja.
Without prejudice to the conclusions referred to in recital 3, it is appropriate to obtain further information on certain specific points.
Brez poseganja v sklepe iz uvodne izjave 3 je primerno pridobiti dodatne informacije o nekaterih posebnih točkah.
Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I to that Directive may be subject to conditions.
Člen 6(1) Direktive 91/414/ES določa, da za vključitev posamezne snovi v Prilogo I k navedeni direktivi lahko veljajo nekateri pogoji.
It is appropriate as regards clofentezine, to require that the notifier carry out a monitoring programme to assess the potential of that substance for long-range atmospheric transport and related environmental risks.
Za klofentezin je primerno zahtevati, da prijavitelj opravi program spremljanja za oceno možnosti prenosa navedene snovi po zraku na dolge razdalje in z njim povezanih okoljskih tveganjih.
Moreover, the notifier shall also submit confirmatory studies in respect of toxicological and environmental risks of clofentezine metabolites.
Poleg tega prijavitelj predloži tudi potrditvene študije o toksikoloških in okoljskih tveganjih metabolitov klofentezina.
It is appropriate as regards diflubenzuron, to require that the notifier submit confirmatory data in respect of the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA).
Za diflubenzuron je primerno zahtevati, da prijavitelj predloži potrditvene podatke o morebitni toksičnosti nečistote in metabolita 4-kloroanilina (PCA).
It is appropriate as regards lenacil, to require that the notifier submit further information on certain soil metabolites which occurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects.
Za lenacil je primerno zahtevati, da prijavitelj predloži dodatne informacije o nekaterih metabolitih v tleh, ki so se pojavili v študijah z lizimetrom, in potrditvene podatke o pridelkih, ki sledijo v kolobarju, vključno z morebitnimi fitotoksičnimi učinki.
If a decision on the classification of lenacil under Council Directive 67/548/EEC [10] identifies the need for further information on the relevance of certain metabolites, the Member States concerned should request the submission of such information.
Če se v sklepu o razvrstitvi lenacila v skladu z Direktivo Sveta 67/548/EGS [10] določi potreba po dodatnih informacijah o pomembnosti nekaterih metabolitov, morajo zadevne države članice zahtevati predložitev takih informacij.
It is appropriate as regards oxadiazon, to require that the notifier submit further information on the potential toxicological relevance of an impurity in the proposed technical specification and on the occurrence of a metabolite in primary crops and rotational crops.
Za oksadiazon je primerno zahtevati, da prijavitelj predloži dodatne informacije o morebitni toksičnosti nečistote v predlaganih tehničnih specifikacijah in pojavu metabolita v primarnih pridelkih in pridelkih, ki sledijo v kolobarju.
In addition, the notifier should be required to submit a metabolism study on ruminants and information on further trials on rotational crops and information on the risk to earthworm-eating birds and mammals and on the long-term risk to fish.
Poleg tega mora prijavitelj predložiti študijo o presnovi pri prežvekovalcih in informacije o nadaljnjih preskusih na pridelkih, ki sledijo v kolobarju, tveganju za ptice in sesalce, ki se hranijo z deževniki, ter dolgoročnem tveganju za ribe.
It is appropriate as regards picloram, to require that the notifier submit confirmatory information in respect of the monitoring analytical method applied in residue trials and a soil photolysis study to confirm the evaluation of picloram degradation.
Za pikloram je primerno zahtevati, da prijavitelj predloži potrditvene informacije o analitični metodi spremljanja, ki se uporablja za preskuse ostankov, in študijo o fotolizi tal za potrditev ocene razgradnje piklorama.
It is appropriate as regards pyriproxifen, to require that the notifier submit information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators.
Za piriproksifen je primerno zahtevati, da prijavitelj predloži informacije, ki potrjujejo oceno tveganja glede tveganja za vodne insekte zaradi piriproksifena in metabolita DPH-pyr ter tveganja zaradi piriproksifena za opraševalce.
Member States shall adopt and publish, by 31 December 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 31. decembra 2010 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
OJ L 172, 2.7.2008, p. 9.
UL L 172, 2.7.2008, str. 9.
EFSA Scientific Report (2009) 269, Conclusion on pesticide peer review regarding the risk assessment of the active substance clofentezine (finalised: 4 June 2009).
Znanstveno poročilo EFSA (2009) 269, Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo klofentezin (dokončano: 4. junija 2009).
EFSA Scientific Report (2009) 332, Conclusion on pesticide peer review regarding the risk assessment of the active substance diflubenzuron (finalised: 16 July 2009).
Znanstveno poročilo EFSA (2009) 332, Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo diflubenzuron (dokončano: 16. julija 2009).
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance lenacil on request from the European Commission.
Evropska agencija za varnost hrane; Sklep o strokovnem pregledu ocene tveganja pesticidov z aktivno snovjo lenacil na zahtevo Evropske komisije.