natgillin/translations-raw huggingface dataset:
The placing on the market of treated articles is subject to the following condition:
Za proizvode, ki lahko povzročajo ostanke v živilih ali krmi, se preveri, ali je treba določiti nove ali spremeniti obstoječe mejne vrednosti ostankov (MRL) v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta ali Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005, in sprejmejo se vsi ustrezni ukrepi za zmanjšanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo.
The person responsible for the placing on the market of a treated article treated with or incorporating acetamiprid shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Za dajanje tretiranih izdelkov na trg velja naslednji pogoj:
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Oseba, odgovorna za dajanje na trg izdelka, ki je tretiran z acetamipridom ali ga vsebuje, zagotovi, da so na oznaki navedenega tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
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 (OJ L 70, 16.3.2005, p. 1).
Uredba (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 152, 16.6.2009, str. 11).
99,0 % w/w
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 (UL L 70, 16.3.2005, str. 1).
Commission Implementing Regulation (EU) 2018/1130
Izvedbena uredba Komisije (EU) 2018/1130
approving cypermethrin as an existing active substance for use in biocidal products of product-type 18
o odobritvi cipermetrina kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 18. vrste proizvodov
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular the third subparagraph of Article 89(1) thereof,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov ter zlasti tretjega pododstavka člena 89(1) Uredbe,
Cypermethrin has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.
Cipermetrin je bil ocenjen za uporabo v 18. vrsti proizvodov (insekticidi, akaricidi in proizvodi za nadzor drugih členonožcev), kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012.
Belgium was designated as a rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 15 April 2015.
Belgija je bila imenovana za državo članico poročevalko in njen pristojni ocenjevalni organ je 15. aprila 2015 predložil poročilo o oceni skupaj s svojimi priporočili.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 5 May 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
V skladu s členom 7(2) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 5. maja 2017 pripravil mnenje Evropske agencije za kemikalije.
According to that opinion, biocidal products of product-type 18 containing cypermethrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Glede na navedeno mnenje je za biocidne proizvode 18. vrste proizvodov, ki vsebujejo cipermetrin, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekatere specifikacije in pogoji za njihovo uporabo.
It is therefore appropriate to approve cypermethrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.
Zato je primerno cipermetrin odobriti za uporabo v biocidnih proizvodih 18. vrste proizvodov, če so izpolnjeni nekatere specifikacije in pogoji.
Furthermore, a need to further investigate the endocrine disrupting potential of cypermethrin has been identified in a screening study carried out in preparation of the impact assessment conducted by the Commission on various options to set criteria to identify endocrine disruptors.
Poleg tega je bila v presejalni študiji, opravljeni v okviru priprave na oceno tveganja Komisije o različnih možnostih določitve meril za opredelitev endokrinih motilcev, ugotovljena potreba po nadaljnji raziskavi cipermetrina kot potencialnega endokrinega motilca.
Depending on the outcome of that assessment, the Commission will consider the need to review the approval of cypermethrin as active substance for use in biocidal products in accordance with Article 15 of Regulation (EU) No 528/2012.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
HAS ADOPTED THIS REGULATION:
Cipermetrin se odobri kot aktivna snov za uporabo v biocidnih proizvodih 18. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Cypermethrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 13. avgusta 2018
Done at Brussels, 13 August 2018.
Predsednik
The President
Delegirana uredba Komisije (EU) št. 1062/2014 z dne 4. avgusta 2014 o delovnem programu za sistematično preverjanje vseh obstoječih aktivnih snovi, ki jih vsebujejo biocidni proizvodi, iz Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta (UL L 294, 10.10.2014, str. 1).
OJ L 167, 27.6.2012, p. 1.
Odbor za biocidne pripravke (BPC), Mnenje o vlogi za odobritev aktivne snovi cipermetrin, 18. vrsta proizvodov (Opinion on the application for approval of the active substance Cypermethrin, Product type: PT 18), ECHA/BPC/153/2017, sprejeto 5. maja 2017.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
Uredba (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS (UL L 309, 24.11.2009, str. 1).
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cypermethrin, Product type: PT 18, ECHA/BPC/153/2017, Adopted on 5 May 2017
PRILOGA
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
Splošno ime
IUPAC Name
Minimalna stopnja čistosti aktivne snovi
Minimum degree of purity of the active substance
Datum prenehanja veljavnosti odobritve
Product type
cipermetrin
Specific conditions
ime po IUPAC:
Cypermethrin
cipermetrin cis:trans 40:60; (RS)-α-ciano-3 fenoksibenzil-(1RS)-cis,trans-3-(2,2-diklorovinil)-2,2-dimetilciklopropan karboksilat
IUPAC Name:
št.
Cypermethrin cis:trans 40:60; (RS)-α-cyano-3 phenoxybenzyl-(1RS)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane carboxylate
ES: 257-842-9
EC No: 257-842-9
št.
Isomeric ratio: cis:trans 40:60
razmerje izomerov: cis:trans 40:60
1 June 2020
1. junij 2020
31 May 2030
31. maj 2030
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ni pa bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
secondary exposure of infants and toddlers;
sekundarni izpostavljenosti dojenčkov in malih otrok;
surface water for:
površinskim vodam v primeru:
surface application indoors; and
nanosa na površino v zaprtih prostorih ter
outdoor wall and perimeter applications in urban areas;
zunanje uporabe na zidovih in okrog stavb na mestnih območjih;
soil for:
tlom v primeru:
surface application indoors;
nanosa na površino v zaprtih prostorih
outdoor wall applications in urban and rural areas; and
zunanje uporabe na zidovih na mestnih in podeželskih območjih ter
perimeter applications in rural areas;
uporabe okrog stavb na podeželskih območjih;
sediment for:
usedlinam v primeru:
surface application, chemical barrier and crack and crevice treatment indoors; and
nanosa na površino, kemične pregrade ter obdelave razpok in rež v zaprtih prostorih ter
groundwater for outdoor wall and perimeter applications in urban areas.
podzemni vodi za zunanjo uporabo na zidovih in okrog stavb na mestnih območjih.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Za proizvode, ki lahko povzročajo ostanke v živilih ali krmi, se preveri, ali je treba določiti nove ali spremeniti obstoječe mejne vrednosti ostankov (MRL) v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta ali Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005, in sprejmejo se vsi ustrezni ukrepi za zmanjšanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Uredba (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 152, 16.6.2009, str. 11).
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 (OJ L 70, 16.3.2005, p. 1).
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 (UL L 70, 16.3.2005, str.
An assessment of the potential endocrine disrupting properties of cypermethrin will also be conducted in the context of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and the conclusions thereof are expected before the end of 2018.
1).
Depending on the outcome of that assessment, the Commission will consider the need to review the approval of cypermethrin as active substance for use in biocidal products in accordance with Article 15 of Regulation (EU) No 528/2012.
Ocena cipermetrina kot potencialnega endokrinega motilca bo opravljena tudi v okviru Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta, ugotovitve iz te ocene pa se pričakujejo pred koncem leta 2018.
Commission Implementing Regulation (EU) 2018/1131
Izvedbena uredba Komisije (EU) 2018/1131
approving penflufen as an active substance for use in biocidal products of product-type 8
o odobritvi penflufena kot aktivne snovi za uporabo v biocidnih proizvodih 8. vrste proizvodov
The evaluating competent authority of the United Kingdom received on 7 July 2015 an application for the approval of the active substance penflufen for use in biocidal products of product-type 8, wood preservatives, as described in Annex V to Regulation (EU) No 528/2012.
Pristojni ocenjevalni organ Združenega kraljestva je 7. julija 2015 prejel vlogo za odobritev aktivne snovi penflufen za uporabo v biocidnih proizvodih v 8. vrste proizvodov, sredstva za zaščito lesa, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012.
The evaluating competent authority of the United Kingdom submitted the assessment report together with its recommendations on 28 February 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
Pristojni ocenjevalni organ Združenega kraljestva je predložil poročilo o oceni, skupaj s svojimi priporočili, 28. februarja 2017 v skladu s členom 8(1) Uredbe (EU) št. 528/2012.
The opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Odbor za biocidne pripravke je ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 14. decembra 2017 oblikoval mnenje Evropske agencije za kemikalije.
According to that opinion, biocidal products of product-type 8 containing penflufen may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Glede na navedeno mnenje je za biocidne proizvode 8. vrste proizvodov, ki vsebujejo penflufen, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjene nekatere specifikacije in pogoji za njihovo uporabo.
It is therefore appropriate to approve penflufen for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.
Zato je primerno penflufen odobriti za uporabo v biocidnih proizvodih 8. vrste proizvodov, pod pogojem, da je to v skladu z nekaterimi specifikacijami in pogoji.
Since the opinion of the European Chemical Agency concludes that penflufen meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, treated articles treated with or incorporating penflufen should be labelled appropriately when placed on the market.
Ker je iz mnenja Evropske agencije za kemikalije razvidno, da penflufen izpolnjuje merila za razvrstitev kot „zelo obstojen“ (vP – very peristent) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006 Evropskega parlamenta in Sveta, bi bilo treba izdelke, ki so tretirani z penflufenom ali ga vsebujejo, ustrezno označiti, ko se dajo na trg.
Penflufen is approved as an active substance for use in biocidal products of product-type 8, subject to the specifications and conditions set out in the Annex.
Penflufen se odobri kot aktivna snov za uporabo v biocidnih proizvodih 8. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Penflufen, Product type: 8, ECHA/BPC/184/2017, Adopted on 14 December 2017.
Odbor za biocidne pripravke (BPC), Mnenje o vlogi za odobritev aktivne snovi penflufen, 8. vrsta proizvodov (Opinion on the application for approval of the active substance Penflufen, Product type: 8), ECHA/BPC/184/2017, sprejeto dne 14. decembra 2017.
IUPAC Name:
5-fluoro-1,3-dimetil-N-2-[(2RS)-4-metilpentan-2-il]fenil-1H-pirazol-4-karboksamid
5-fluoro-1,3-dimethyl-N-2-[(2RS)-4-methylpentan-2-yl]phenyl-1H-pyrazole-4-carboxamide
Št.
EC No: not available
ES: ni na voljo
CAS No: 494793-67-8
Št.
1 February 2019
980g/kg (enantiomeri v razmerju 1:1 (R:S)
31 January 2029
1. februar 2019
The authorisations of biocidal products are subject to the following conditions:
31. januar 2029
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Dovoljenja za biocidne proizvode se izdajo pod naslednjima pogojema:
industrial and professional users;
Zaradi ugotovljenih tveganj v zvezi z ocenjenimi uporabami se pri oceni proizvoda posebna pozornost nameni:
soil and groundwater for wood in service that will be exposed to frequent weathering.
industrijskim in poklicnim uporabnikom;
In view of the risks identified for soil, labels, and, where provided, safety data sheets of product authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.
tlom in podzemni vodi pri gradbenem lesu, ki bo izpostavljen pogostemu preparevanju.
The placing on the market of treated articles is subject to the following condition:
Zaradi ugotovljenih tveganj za tla se na oznakah in po potrebi na varnostnih listih dovoljenega proizvoda navede, da industrijska uporaba poteka na zaprtem območju ali na neprepustni trdni podlagi z ogrado, da se sveže obdelani les po obdelavi hrani pod zaščitno streho in/ali na neprepustni trdni podlagi, s čimer se prepreči neposredno izlivanje proizvodov v tla ali vodo, ter da se izgube pri uporabi proizvoda zbirajo za ponovno uporabo ali odstranjevanje.
The person responsible for the placing on the market of a treated article treated with or incorporating penflufen shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Za dajanje tretiranih izdelkov na trg velja naslednji pogoj:
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Oseba, odgovorna za dajanje na trg izdelka, ki je tretiran s penflufenom ali ga vsebuje, zagotovi, da so na oznaki navedenega tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Commission Implementing Regulation (EU) 2018/1132
Izvedbena uredba Komisije (EU) 2018/1132
authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
o odobritvi spremembe poimenovanja in posebne zahteve za označevanje novega živila sintetični zeaksantin na podlagi Uredbe (EU) 2015/2283 Evropskega parlamenta in Sveta ter o spremembi Izvedbene uredbe Komisije (EU) 2017/2470
Natural zeaxanthin is a component of the normal human diet as it is found in many fruits and green vegetables as well as in egg yolk.
Naravni zeaksantin je sestavina v običajni prehrani ljudi, saj ga vsebujejo številne vrste sadja in zelene zelenjave ter jajčni rumenjak.
It is also currently used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council.
Uporablja se tudi v prehranskih dopolnilih, kot so opredeljena v Direktivi 2002/46/ES Evropskega parlamenta in Sveta.
Commission Implementing Decision 2013/49/EU authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council, the placing on the market of synthetic zeaxanthin as a novel food ingredient in food supplements at the maximum intake of up to 2 mg per day.
Z Izvedbenim sklepom Komisije 2013/49/EU je bilo v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta odobreno dajanje na trg sintetičnega zeaksantina kot nove živilske sestavine v prehranskih dopolnilih pri največjem vnosu do 2 mg na dan.
The designation of synthetic zeaxanthin authorised by Implementing Decision 2013/49/EU on the labelling of the foodstuffs containing it is ‘synthetic zeaxanthin’.
Poimenovanje sintetičnega zeaksantina, odobrenega z Izvedbenim sklepom 2013/49/EU, pri označevanju živil, ki ga vsebujejo, je „sintetični zeaksantin“.
On 23 February 2018, the company DSM Nutritional Products Europe (‘the Applicant’) made a request to the Commission to authorise the amendment of the designation and of the specific labelling requirements for synthetic zeaxanthin within the meaning of Article 10(1) of Regulation (EU) 2015/2283.
Družba DSM Nutritional Products Europe („vložnik“) je 23. februarja 2018 pri Komisiji vložila zahtevek za odobritev spremembe poimenovanja in posebnih zahtev za označevanje sintetičnega zeaksantina v smislu člena 10(1) Uredbe (EU) 2015/2283.
The application requests the deletion of the term ‘synthetic’ from the designation of the novel food as listed in the Union list and from the labelling of foodstuffs containing it.
V zahtevku je zaprosila za črtanje izraza „sintetični“ iz poimenovanja novega živila, kakor je navedeno na seznamu Unije, in iz označevanja živil, ki ga vsebujejo.
The Applicant considers that the change of the designation and the labelling requirements of zeaxanthin is necessary to alleviate any potential negative economic impact that the use of the term ‘synthetic’ on the labelling of food supplements containing synthetic zeaxanthin may cause due to the negative connotation of the term ‘synthetic’.
Vložnik meni, da je sprememba poimenovanja in zahtev za označevanje zeaksantina potrebna, da se ublaži morebitni negativni ekonomski učinek, ki bi lahko nastal zaradi uporabe izraza „sintetični“ na oznakah prehranskih dopolnil, ki vsebujejo sintetični zeaksantin, zaradi negativnega prizvoka izraza „sintetični“.
The Applicant also claims that such potential negative economic impact is most probably not experienced by economic operators placing on the market food supplements containing authorised synthetic novel foods which do not carry the term ‘synthetic’ on their labelling.
Vložnik tudi trdi, da gospodarski subjekti, ki dajejo na trg prehranska dopolnila, ki vsebujejo odobrena sintetična nova živila, vendar pri označevanju nimajo izraza „sintetični“, najverjetneje ne občutijo takšnega morebitnega ekonomskega učinka.
There are a number of synthetic substances currently authorised and listed in the Union list of novel foods, of which the counterparts from natural origin exist, and both forms are used in food supplements.
Trenutno je odobrenih in na seznamu Unije novih živil navedenih več sintetičnih snovi, ki imajo ekvivalente naravnega porekla, kot prehransko dopolnilo pa se uporabljata obe obliki.
However those synthetic substances are not designated as synthetic in the Union list and are not labelled as such.
Vendar navedene sintetične snovi na seznamu Unije niso poimenovane kot sintetične in tudi niso označene kot takšne.