natgillin/translations-raw huggingface dataset:
The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 3 March 2006 for ethoprophos, on 10 August 2005 for pirimiphos-methyl, on 3 March 2006 for fipronil, in the format of the EFSA Scientific Reports [4].
Poročila o oceni so pregledali strokovnjaki držav članic in EFSA ter jih Komisiji v obliki znanstvenih poročil EFSA predložili 3. marca 2006 za etoprofos, 10. avgusta 2005 za pirimifos-metil in 3. marca 2006 za fipronil [4].
These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 March 2007 in the format of the Commission review reports for ethoprophos, pirimiphos-methyl and fipronil.
Ta poročila so države članice in Komisija pregledale v okviru Stalnega odbora za prehranjevalno verigo in zdravje živali ter končno različico pripravile 16. marca 2007 v obliki poročil Komisije o pregledu glede etoprofosa, pirimifos-metila in fipronila.
It has appeared from the various examinations made that plant protection products containing ethoprophos, pirimiphos-methyl and fipronil 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 reports.
Različne preiskave so pokazale, da se za fitofarmacevtska sredstva, ki vsebujejo etoprofos, pirimifos-metil in fipronil, 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 poročilih Komisije o pregledu.
It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.
Zato je primerno vključiti te aktivne snovi v Prilogo I, da se v vseh državah članicah v skladu z določbami navedene direktive lahko odobri registracija fitofarmacevtskih sredstev, ki vsebujejo te aktivne snovi.
Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points concerning ethoprophos, pirimiphos-methyl and fipronil.
Brez poseganja v navedeni sklep je primerno pridobiti dodatne informacije o nekaterih posameznih točkah v zvezi z etoprofosom, pirimifos-metilom in fipronilom.
Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions.
Člen 6(1) Direktive 91/414/EGS določa, da za vključitev posamezne snovi v Prilogo I lahko veljajo nekateri pogoji.
Therefore it is appropriate to require that ethoprophos, pirimiphos-methyl and fipronil should be subjected to further testing for confirmation of the risk assessment for some issues and that such studies should be presented by the notifiers.
Zato je primerno zahtevati, da se za etoprofos, pirimifos-metil in fipronil izvedejo dodatna testiranja za potrditev ocene tveganja na nekaterih področjih in da prijavitelji predložijo takšne študije.
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 ethoprophos, pirimiphos-methyl and fipronil 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 etoprofos, pirimifos-metil in fipronil, 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.
The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 [5] has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data.
Izkušnje iz prejšnjih vključitev aktivnih snovi, ocenjenih na podlagi Uredbe Komisije (EGS) št. 3600/92 [5], v Prilogo I k Direktivi 91/414/EGS so pokazale, da lahko pride do težav pri razlagi dolžnosti imetnikov obstoječih registracij v zvezi z dostopom do podatkov.
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.
V izogib nadaljnjim težavam se zato zdi nujno razjasniti dolžnosti držav članic, zlasti dolžnost, da preverijo, ali ima imetnik registracije dostop do dokumentacije, ki izpolnjuje pogoje iz Priloge II k navedeni direktivi.
Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing ethoprophos, pirimiphos-methyl and fipronil as active substances by 31 March 2008.
Države članice v skladu z Direktivo 91/414/EGS do 31. marca 2008 po potrebi spremenijo ali prekličejo obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo etoprofos, pirimifos-metil in fipronil kot aktivne snovi.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to ethoprophos, pirimiphos-methyl and fipronil 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 etoprofosom, pirimifos-metilom in fipronilom, 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 ethoprophos, pirimiphos-methyl and fipronil 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 30 September 2007 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 ethoprophos, pirimiphos-methyl and fipronil respectively.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje etoprofos, pirimifos-metil in fipronil kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo I k Direktivi 91/414/EGS najpozneje do 30. septembra 2007, 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 etoprofosu, pirimifos-metilu in fipronilu v tem zaporedju iz Priloge I k navedeni direktivi.
in the case of a product containing ethoprophos, pirimiphos-methyl or fipronil as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2011 at the latest; or
če sredstvo vsebuje etoprofos, pirimifos-metil ali fipronil kot edino aktivno snov, najpozneje do 30. septembra 2011 po potrebi spremenijo ali prekličejo registracijo; ali
in the case of a product containing ethoprophos, pirimiphos-methyl or fipronil as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2011 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 etoprofos, pirimifos-metil ali fipronil kot eno izmed več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 30. septembra 2011 ali do datuma, določenega za takšno spremembo ali preklic v ustrezni direktivi ali direktivah, ki so zadevno snov ali snovi dodale v Prilogo I k Direktivi 91/414/EGS, pri čemer se upošteva poznejši datum.
Done at Brussels, 16 August 2007.
V Bruslju, 16. avgusta 2007
Common name, identification Nos
Splošno ime, identifikacijske številke
CAS No: 13194-48-4
Št. CAS: 13194-48-4
CIPAC No: 218
Št. CIPAC: 218
O-ethyl S,S-dipropyl phosphorodithioate
O-etil S,S-dipropil fosforoditioat
Only uses as nematicide and insecticide in soil application can be authorised.
Registrira se lahko samo kot nematicid in insekticid za uporabo v zemlji.
Authorisations should be limited to professional users.
Registracije je treba omejiti na profesionalne uporabnike.
In assessing applications to authorise plant protection products containing ethoprophos for uses other than potatoes not cultivated for human or animal consumption, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
Pri ocenjevanju zahtevkov za registracijo fitofarmacevtskih sredstev, ki vsebujejo etoprofos, za druge vrste uporabe kot za krompir, ki ni namenjen prehrani ljudi ali živali, so države članice zlasti pozorne na merila iz člena 4(1)(b) in zagotovijo, da se pred takšno registracijo predložijo vsi potrebni podatki in informacije.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethoprophos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za etoprofos ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 16. marca 2007.
the residues and evaluate the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,
ostanke in oceno izpostavljenosti potrošnikov prek vnosa hrane zaradi prihodnjih sprememb mejnih vrednosti ostankov,
the operator safety.
varnost izvajalcev tretiranja.
Authorised conditions of use must prescribe the application of adequate personal and respiratory protective equipment and other risk mitigation measures such as the use of closed transfer system for the distribution of the product,
V pogojih uporabe morajo biti predpisani uporaba ustrezne osebne zaščitne opreme in opreme za zaščito dihal ter drugi ukrepi za zmanjšanje tveganja, kot so uporaba zaprtega prenosnega sistema za vnos proizvoda,
the protection of birds, mammals, aquatic organisms, surface and groundwater under vulnerable conditions.
zaščito ptic, sesalcev, vodnih organizmov ter površinske in podzemne vode v občutljivih razmerah.
Conditions of authorisation should include risk mitigation measures, such as buffer zones and the achievement of complete incorporation of granules in the soil.
Pogoji za registracijo morajo vključevati ukrepe za zmanjšanje tveganja, kot so varnostni pasovi in zagotovitev popolnega vnosa zrn v zemljo.
The concerned Member States shall request the submission of further studies to confirm the short and long term risk assessment for birds and for earthworms eating mammals.
Zadevne države članice zahtevajo predložitev dodatnih študij za potrditev kratkoročne in dolgoročne ocene tveganja za ptice in sesalce, ki se prehranjujejo z deževniki.
They shall ensure that the notifiers at whose request ethoprophos has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
Zagotovijo, da prijavitelji, ki so zahtevali vključitev etoprofosa v to prilogo, predložijo te študije Komisiji v 2 letih od začetka veljavnosti te direktive.
pirimiphos-methyl
Pirimifos-metil
CAS No: 29232-93-7
Št. CAS: 29232-93-7
CIPAC No: 239
Št. CIPAC: 239
O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate
O-2-dietilamino-6-metilpirimidin-4-il O,O-dimetilfosforotioat
Only uses as insecticide for post-harvest storage can be authorised.
Registrira se lahko samo kot insekticid za tretiranje pridelka po spravilu.
In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
Pri ocenjevanju zahtevkov za registracijo fitofarmacevtskih sredstev, ki vsebujejo pirimifos-metil, za druge vrste uporabe kot z avtomatskimi sistemi v praznih skladiščih za žita so države članice zlasti pozorne na merila iz člena 4(1)(b) in zagotovijo, da se pred takšno registracijo predložijo vsi potrebni podatki in informacije.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pirimiphos-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za pirimifos-metil ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 16. marca 2007.
the operators safety.
varnost izvajalcev tretiranja.
Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure,
V pogojih uporabe morajo biti predpisani uporaba ustrezne osebne zaščitne opreme in opreme za zaščito dihal ter ukrepi za zmanjšanje tveganja z namenom zmanjšati izpostavljenost,
the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.
izpostavljenost potrošnikov prek vnosa hrane zaradi prihodnjih sprememb mejnih vrednosti ostankov,
The Member States concerned shall request the submission of further studies to confirm the operator exposure assessment.
Zadevne države članice zahtevajo predložitev dodatnih študij za potrditev ocene tveganja izpostavljenosti izvajalcev tretiranja.
They shall ensure that the notifiers at whose request pirimiphos-methyl has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
Zagotovijo, da prijavitelji, ki so zahtevali vključitev pirimifos-metila v to prilogo, predložijo te študije Komisiji v 2 letih od začetka veljavnosti te direktive.
CAS No: 120068-37-3
Št. CAS: 120068-37-3
CIPAC No: 581
Št. CIPAC: 581
(±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinylpyrazole-3-carbonitrile
(±)-5-amino-1-(2,6-dikloro-α,α,α-trifluoro-para-tolil)-4-trifluorometilsulfinil-pirazol-3-karbonitril
Only uses as insecticide for use as seed treatment may be authorised.
Registrira se lahko samo kot insekticid za tretiranje semena.
The seed coating shall only be performed in professional seed treatment facilities.
Piliranje semena se izvaja samo v profesionalnih objektih za tretiranje semena.
These facilities must apply the best available techniques in order to ensure that the release of dust clouds during storage, transport and application can be excluded.
V teh objektih je treba uporabljati najboljše razpoložljive tehnike, da se prepreči izpust oblakov prahu med skladiščenjem, prevozom in uporabo.
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fipronil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 March 2007 shall be taken into account.
Za izvajanje enotnih načel iz Priloge VI se upoštevajo sklepi poročila o pregledu za fipronil ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 16. marca 2007.
the packaging of the marketed products to avoid the generation of photo-degradation products of concern,
pakiranje trženih sredstev, da se prepreči fotorazgradnja zadevnih sredstev,
the potential for groundwater contamination, especially from metabolites which are more persistent than the parent compound, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,
nevarnost za onesnaženje podzemne vode, zlasti z metaboliti, ki so bolj obstojni kot izhodna spojina, kadar se aktivna snov uporablja na območjih z občutljivo zemljo in/ali podnebnimi razmerami,
the protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and honey bees,
zaščito semenojedih ptic in sesalcev, vodnih organizmov, neciljnih členonožcev in medonosnih čebel,
the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application.
uporabo ustrezne opreme, ki zagotavlja visoko raven vnosa v zemljo in čim manjše razlitje med uporabo.
The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds and mammals, and honey bees, especially bee brood.
Zadevne države članice zahtevajo predložitev nadaljnjih študij za potrditev ocene tveganja za semenojede ptice, sesalce in medonosne čebele, zlasti zalego.
They shall ensure that the notifier at whose request fipronil has been included in this Annex provide such studies to the Commission within one year from the entry into force of this Directive.’
Zagotovijo, da prijavitelj, ki je zahteval vključitev fipronila v to prilogo, predloži te študije Komisiji v 1 letu od začetka veljavnosti te direktive.“
Commission Directive 2007/53/EC
Direktiva Komisije 2007/53/ES
amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress
o spremembi Direktive Sveta 76/768/EGS v zvezi s kozmetičnimi izdelki zaradi prilagoditve Priloge III k tej direktivi tehničnemu napredku
Fluorine compounds are currently listed in and subject to restrictions and conditions laid down in Annex III, Part 1 of Directive 76/768/EEC.
Fluorove spojine so trenutno navedene v delu 1 Priloge III k Direktivi 76/768/EGS in zanje že veljajo tam določene omejitve in pogoji.
The Scientific Committee on Consumer Products (SCCP) is of the opinion that if the sole source of fluoride exposure is toothpaste containing fluoride between 1000 to 1500 ppm, there is a minimal concern that children under the age of six will develop fluorosis, provided that such toothpaste is used as recommended.
Znanstveni odbor za potrošniške izdelke meni, da ni večje skrbi, da bi zobna pasta z vsebnostjo 1000–1500 ppm fluorida pri otrocih, starih manj kot šest let, povzročila fluorozo, če je edini vir izpostavljenosti fluoridu in če se uporablja po navodilih.
Therefore, reference numbers 26 to 43, and reference numbers 47 and 56 of Annex III, Part 1 should be amended accordingly.
Zato je treba referenčne številke 26 do 43 in referenčne številke 47 do 56 iz dela 1 Priloge III ustrezno spremeniti.
Annex III of Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
Priloga III k Direktivi 76/768/EGS se spremeni skladno s Prilogo k tej direktivi.
Member States shall adopt and publish, by 19 April 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 19. aprila 2008 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall forthwith communicate to the Commission the text of those provisions together with a correlation table of those provisions and this Directive.
Komisiji takoj posredujejo besedila navedenih predpisov in korelacijsko tabelo med navedenimi predpisi in to direktivo.
They shall apply those provisions from 19 January 2009.
Navedene predpise uporabljajo od 19. januarja 2009.
Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.
Države članice sporočijo Komisiji besedila temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.
Directive last amended by Commission Directive 2007/22/EC (OJ L 101, 18.4.2007, p. 11).
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2007/22/ES (UL L 101, 18.4.2007, str. 11).
In reference numbers 26 to 43, and reference numbers 47 and 56 of Part 1 of Annex III to Directive 76/768/EEC, the following text is added after each entry in column f:
Pri referenčnih številkah 26 do 43 in referenčnih številkah 47 do 56 iz dela 1 Priloge III k Direktivi 76/768/EGS se za vsakim vnosom v stolpcu f doda naslednje besedilo:
‘For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
„Zobne kreme z vsebnostjo 0,1–0,15 % fluora, razen če niso že označene kot neprimerne za otroke (npr. ‚samo za uporabo pri odraslih‘), je treba označiti z naslednjim besedilom:
“Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.
‚Otroci, stari do 6 let: da preprečite zaužitje, uporabite za grah zobne kreme pod nadzorovanim ščetkanjem.
In case of intake of fluoride from other sources consult a dentist or doctor.”’
Pri vnosu fluora iz drugih virov se posvetujte s svojim zobozdravnikom ali zdravnikom.‘“
Commission Directive 2007/54/EC
Direktiva Komisije 2007/54/ES
amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress
o spremembi Direktive Sveta 76/768/EGS glede kozmetičnih izdelkov z namenom prilagoditve prilog II in III k navedeni direktivi tehničnemu napredku
Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/EC [2], concluded that the potential risks were of concern.
Po objavi znanstvene študije leta 2001 z naslovom „Uporaba trajnih barv za lase in tveganje za nastanek raka na mehurju“ je Znanstveni odbor za kozmetične in neprehrambene izdelke, namenjene potrošnikom (SCCP), ki ga je na podlagi Sklepa Komisije 2004/210/ES [2] nadomestil Znanstveni odbor za potrošniške izdelke, sklenil, da je morebitna tveganja treba vzeti resno.
It recommended that the Commission take further steps to control the use of hair dye substances.
Predlagal je, da Komisija sprejme nadaljnje ukrepe za nadzor uporabe snovi v barvah za lase.
The Scientific Committee on Consumer Products further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.
Znanstveni odbor za potrošniške izdelke je priporočil tudi celostno strategijo ocenjevanja varnosti snovi v barvah za lase, vključno z zahtevami za preskušanje snovi, ki se uporabljajo v izdelkih za barvanje las glede njihove morebitne genotoksičnosti/mutagenosti.