natgillin/translations-raw huggingface dataset:
Pursuant to Regulation (EC) No 1451/2007, magnesium phosphide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, as defined in Annex V to that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja magnezijevega fosfida glede uporabe v 18. vrsti izdelkov, insekticidih, kot je opredeljena v Prilogi V k navedeni direktivi.
Germany was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 26 October 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Nemčija, ki je bila imenovana za državo članico poročevalko, je 26. oktobra 2007 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 17 September 2009, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda 17. septembra 2009 v Stalnem odboru za biocidne pripravke vključene v poročilo o oceni.
It appears from the examinations made that biocidal products used as insecticides and containing magnesium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot insekticidi in vsebujejo magnezijev fosfid, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include magnesium phosphide in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as insecticides and containing magnesium phosphide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je primerno vključiti magnezijev fosfid v Prilogo I, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot insekticidi in vsebujejo magnezijev fosfid.
Not all potential uses have been evaluated at the Union level.
Na ravni Unije ni bila opravljena presoja vseh možnih uporab.
It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno, da države članice ocenijo scenarije uporabe ali izpostavljenosti in tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni Unije, ter da pri izdaji dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
In particular, where relevant, Member States should assess outdoor use, which has not been addressed in the Union level risk assessment.
Države članice bi morale, po potrebi, zlasti oceniti uporabo na prostem, ki ni bila obravnavana v oceni tveganja na ravni Unije.
In the light of the conclusions of the assessment report, it is appropriate to require that products containing magnesium phosphide and used as insecticides be authorised only for use by trained professionals in accordance with Article 10(2)(i)(e) of Directive 98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to such products.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se v skladu s členom 10(2)(i)(e) Direktive 98/8/ES pri izdaji dovoljenj za pripravke, ki vsebujejo magnezijev fosfid in se uporabljajo kot insekticidi, uporaba dovoli samo usposobljenim strokovnjakom in da se uporabijo posebni ukrepi za zmanjšanje tveganja.
Such measures should be aimed at limiting the risk of exposure of users to magnesium phosphide to an acceptable level.
Ti ukrepi morajo biti usmerjeni k omejitvi tveganja izpostavljenosti uporabnikov magnezijevemu fosfidu na sprejemljivo raven.
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC [3] establishes maximum limits for magnesium phosphide residues which are present in or on food and feed.
Uredba Evropskega parlamenta in Sveta (ES) št. 396/2005 z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora ter o spremembi Direktive Sveta 91/414/EGS [3] določa mejne vrednosti ostankov magnezijevega fosfida, ki so prisotni v ali na hrani in krmi.
Pursuant to Article 3(2)(c) of Regulation (EC) No 396/2005, the maximum residue limits apply to any pesticide residues, including those which may arise as a result of use as a biocide.
Na podlagi člena 3(2)(c) Uredbe (ES) št. 396/2005 se mejne vrednosti ostankov uporabljajo za ostanke pesticidov, vključno s tistimi, ki lahko nastajajo kot posledica njihove uporabe kot biocidov.
Member States should ensure that adequate residue trials are provided at product authorisation to allow consumer risk assessment.
Države članice morajo ob izdaji dovoljenj za pripravke zagotoviti ustrezne preskuse za ugotavljanje ostankov, da bi omogočile oceniti tveganje za potrošnike.
Furthermore, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005.
Nadalje morajo oznake in/ali varnostni listi dovoljenih proizvodov vsebovati navodila za uporabo, kot je upoštevanje karence, kar zagotavlja skladnost z določbami iz člena 18 Uredbe (ES) št. 396/2005.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance magnesium phosphide and also to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov magnezijev fosfid, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 18 containing magnesium phosphide to ensure that they comply with Directive 98/8/EC.
Državam članicam je treba po vključitvi zagotoviti ustrezno obdobje za izvedbo člena 16(3) Direktive 98/8/ES in zlasti za izdajo, spremembo ali razveljavitev dovoljenj za biocidne pripravke v 18. vrsti izdelkov, ki vsebujejo magnezijev fosfid, da se zagotovi njihova skladnost z Direktivo 98/8/ES.
Member States shall adopt and publish, by 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. januarja 2011.
They shall apply those provisions from 1 February 2012.
Navedene predpise uporabljajo od 1. februarja 2012.
The following entry for the substance magnesium phosphide releasing phosphine is inserted in Annex I to Directive 98/8/EC:
V Prilogo I k Direktivi 98/8/ES se vstavi naslednji vnos za snov magnezijev fosfid, ki sprošča fosfin:
Magnesium phosphide releasing phosphine
magnezijev fosfid, ki sprošča fosfin
Trimagnesium diphosphide
trimagnezijev difosfid
EC No: 235-023-7
št. ES: 235-023-7
CAS No: 12057-74-8
št. CAS: 12057-74-8
1 February 2012
februar 2012
31 January 2014
januar 2014
31 January 2022
januar 2022
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the Union level risk assessment.
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vloge za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo tiste scenarije uporabe ali izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni Unije.
In particular, where relevant, Member States shall assess outdoor use.
Države članice, po potrebi, zlasti ocenijo uporabo na prostem.
When granting product authorisation, Member States shall ensure that adequate residue trials are provided to allow consumer risk assessment and that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
Pri izdaji dovoljenj za pripravke države članice zagotovijo ustrezne preskuse za ugotavljanje ostankov, da omogočijo potrošnikom oceno tveganja, in da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj.
Products shall only be supplied to and used by specifically trained professionals in the form of ready-for-use products.
Pripravki se lahko dobavijo samo posebej usposobljenim strokovnjakom, ki jih edini lahko uporabljajo, v obliki pripravkov, pripravljenih za uporabo.
Those include, amongst others, the use of appropriate personal and respiratory protective equipment, the use of applicators and the presentation of the product in a form designed to reduce the exposure of operators to an acceptable level.
Ti med drugim vključujejo uporabo ustrezne osebne zaščitne opreme in opreme za zaščito dihal, uporabo nanašalcev in pakiranje pripravka v obliki, ki izpostavljenost uporabnikov zmanjša na sprejemljivo raven.
For indoor use, those include also the protection of operators and workers during fumigation, the protection of workers at re-entry (after fumigation period) and the protection of bystanders against leaking of gas.
Pri uporabi v zaprtih prostorih vključujejo ukrepi tudi zaščito uporabnikov in delavcev med zaplinjevanjem, zaščito delavcev pri ponovnem vstopu v prostore (po končanem zaplinjevanju) in zaščito morebitnih navzočih pred uhajanjem plina.
For products containing magnesium phosphide that may lead to residues in food or feed, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).’
Za pripravke, ki vsebujejo magnezijev fosfid in lahko puščajo ostanke v živilih ali krmi, morajo oznake in/ali varnostni listi dovoljenih proizvodov vsebovati navodila za uporabo, kot je upoštevanje karence, ki zagotavljajo skladnost z določbami iz člena 18 Uredbe (ES) št. 396/2005 Evropskega parlamenta in Sveta (UL L 70, 16.3.2005, str. 1.“).
Commission Directive 2010/8/EU
Direktiva Komisije 2010/8/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev varfarin natrija kot aktivne snovi v Prilogo I k Direktivi
That list includes warfarin sodium.
Navedeni seznam vključuje varfarin natrij.
Pursuant to Regulation (EC) No 1451/2007, warfarin sodium has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja varfarin natrija glede uporabe v 14. vrsti izdelkov, rodenticidih, kot so opredeljeni v Prilogi V k Direktivi 98/8/ES.
Ireland was designated as Rapporteur Member State and submitted its report, together with a recommendation, to the Commission on 3 October 2005 in accordance with Article 14(4) and 14(6) of Regulation (EC) No 1451/2007.
Irska, ki je bila imenovana za državo članico poročevalko, je 3. oktobra 2005 v skladu s členom 14(4) in 14(6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo in priporočilo.
It appears from the examinations made that biocidal products used as rodenticides and containing warfarin sodium may be expected not to present a risk to humans except for accidental incidents with children.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot rodenticidi in vsebujejo varfarin natrij, mogoče pričakovati, da za ljudi ne pomenijo tveganja, razen pri naključnih incidentih z otroki.
However, warfarin sodium is for the time being considered essential for reasons of public health and hygiene.
Trenutno zaradi javnega zdravja in higiene varfarin natrij velja za nujnega.
It is therefore appropriate to include warfarin sodium in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing warfarin sodium can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je primerno vključiti varfarin natrij v Prilogo I, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot rodenticidi in vsebujejo varfarin natrij.
In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing warfarin sodium and used as rodenticides.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se pri izdaji dovoljenj za pripravke, ki vsebujejo varfarin natrij in se uporabljajo kot rodenticid, uporabijo posebni ukrepi za zmanjšanje tveganja.
To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed for all rodenticides containing warfarin sodium, while other conditions should be imposed by the Member States on a case by case basis.
Zato je treba za vse rodenticide, ki vsebujejo varfarin natrij, uvesti nekatere omejitve, kot na primer največjo koncentracijo, prepoved trženja aktivne snovi v izdelkih, ki niso že pripravljeni za uporabo, in uporabo averzivnih sredstev, druge pogoje pa bi morale za vsak primer posebej uvesti države članice.
In view of the identified risks, warfarin sodium should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.
Zaradi ugotovljenih tveganj je treba varfarin natrij vključiti v Prilogo I samo za pet let, pred njegovo ponovno vključitvijo pa je treba v skladu z drugim pododstavkom člena 10(5)(i) Direktive 98/8/ES izvesti primerljivo oceno tveganja.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance warfarin sodium and to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov varfarin natrij, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
Pred vključitvijo aktivne snovi v Prilogo I je treba zagotoviti ustrezno obdobje, ki bo omogočilo državam članicam in zainteresiranim stranem, da se pripravijo na izpolnjevanje novih zahtev, in predlagateljem, ki so pripravili dokumentacijo, da lahko povsem izkoristijo desetletno obdobje za varstvo podatkov, ki se v skladu s členom 12(1)(c)(ii) Direktive 98/8/ES začne z dnem vključitve.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing warfarin sodium to ensure that they comply with Directive 98/8/EC.
Državam članicam je treba po vključitvi zagotoviti ustrezno obdobje za izvedbo člena 16(3) Direktive 98/8/ES in zlasti za izdajo, spremembo ali razveljavitev dovoljenj za biocidne pripravke v 14. vrsti izdelkov, ki vsebujejo varfarin natrij, da se zagotovi njihova skladnost z Direktivo 98/8/ES.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedila temeljnih predpisov nacionalne zakonodaje, ki jih sprejmejo na področju, ki ga ureja ta direktiva.
The following entry for the substance warfarin sodium is added in Annex I to Directive 98/8/EC:
V Prilogi I k Direktivi 98/8/ES se doda snov varfarin natrij:
Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate
Natrijev 2-okso-3-(3-okso-1-fenilbutil) kromen-4-olat
EC No: 204-929-4
Št. ES: 204-929-4
CAS No: 129-06-6
Št. CAS: 129-06-6
The active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
Pred ponovno vključitvijo aktivne snovi v to prilogo je treba izvesti primerjalno oceno tveganja v skladu z drugim pododstavkom člena 10(5)(i) Direktive 98/8/ES.
the nominal concentration of the active substance shall not exceed 790 mg/kg and only ready-for-use products shall be authorised;
Nazivna koncentracija aktivne snovi ne presega 790 mg/kg, dovoljenje pa se izda samo za uporabo pripravljenih proizvodov.
products shall contain an aversive agent and, where appropriate, a dye;
Pripravki vsebujejo averzivno sredstvo in po potrebi barvilo.
primary and secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures.
Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
These include, amongst others, the possibility of restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’
Ti med drugim po potrebi vključujejo omejitev pripravka za poklicno rabo, določitev največje velikosti embalaže ter določitev zahtev za uporabo vab, zaščitenih pred nepooblaščenimi posegi.“
Commission Directive 2010/9/EU
Direktiva Komisije 2010/9/EU
amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance aluminium phosphide releasing phosphine to product type 18 as defined in Annex V thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za razširitev vključitve aluminijevega fosfida, ki sprošča fosfin, kot aktivne snovi v Prilogo I k Direktivi na 18. vrsto izdelkov, opredeljenih v Prilogi V k navedeni uredbi
Commission Directive 2009/95/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include aluminium phosphide releasing phosphine as an active substance in Annex I thereto [3] included aluminium phosphide as an active substance in Annex I to Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.
Z Direktivo Komisije 2009/95/ES z dne 31. julija 2009 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev aluminijevega fosfida, ki sprošča fosfin, kot aktivne snovi v Prilogo I k Direktivi [3] je bil aluminijev fosfid kot aktivna snov vključen v Prilogo I k Direktivi 98/8/ES za uporabo v 14. vrsti izdelkov, rodenticidih, kot je opredeljena v Prilogi V k Direktivi 98/8/ES.
Pursuant to Regulation (EC) No 1451/2007, aluminium phosphide has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, as defined in Annex V to that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja aluminijevega fosfida glede uporabe v 18. vrsti izdelkov, insekticidih, kot je opredeljena v Prilogi V k navedeni direktivi.
Germany was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 26 October 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Nemčija, ki je bila imenovana za državo članico poročevalko, je 26. oktobra 2007 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
It appears from the examinations made that biocidal products used as insecticides and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot insekticidi in vsebujejo aluminijev fosfid, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include aluminium phosphide in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as insecticides and containing aluminium phosphide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.
Zato je primerno vključiti aluminijev fosfid v Prilogo I, da se v vseh državah članicah v skladu s členom 16(3) Direktive 98/8/ES zagotovi, da se izdajo, spremenijo ali razveljavijo dovoljenja za biocidne pripravke, ki se uporabljajo kot insekticidi in vsebujejo aluminijev fosfid.
It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno, da države članice ocenijo scenarije uporabe ali izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni Unije, ter da pri izdaji dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
In particular, where relevant, Member States should assess outdoor use, which has not been addressed in the Union level risk assessment.
Države članice bi morale po potrebi zlasti oceniti uporabo na prostem, ki ni bila obravnavana v oceni tveganja na ravni Unije.