natgillin/translations-raw huggingface dataset:
Products shall not be authorised for use in sewers, open area or waste dumps.
Proizvodi, ki so pripravki v razsuti obliki vab, kot so zrna ali peleti, se odobrijo samo v pripravkih, ki se dobavijo v vrečkah ali drugi embalaži, da se zmanjša izpostavljenost ljudi in okolja.
Persons making products for professional users available on the market shall make sure that these products are not supplied to the general public.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo poklicni uporabniki, izdajo pod naslednjimi pogoji:
In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:
Proizvodi se ne odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
Products may be authorised for use in sewers, open area or waste dumps.
Osebe, ki dajejo proizvode, namenjene poklicnim uporabnikom, na trg, zagotovijo, da se proizvodi ne dobavljajo za splošno uporabo.
Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations.
Poleg splošnih pogojev se dovoljenja za biocidne proizvode, ki jih uporabljajo usposobljeni poklicni uporabniki, izdajo pod naslednjimi pogoji:
Persons making products for trained professional users available on the market shall make sure that the products are not supplied to other persons than trained professionals.
Proizvodi se lahko odobrijo za uporabo v kanalizaciji, na odprtih območjih ali na odlagališčih odpadkov.
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Proizvodi se lahko odobrijo za uporabo na pokritih in zaščitenih točkah nastavitve vab, če neciljnim vrstam in ljudem zagotavljajo enako raven zaščite kot mesta nastavitve vab, ki so zavarovana pred nepooblaščenimi posegi.
Commission Implementing Regulation (EU) 2017/1379
Izvedbena uredba Komisije (EU) 2017/1379
renewing the approval of difenacoum as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve difenakuma kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance difenacoum is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov difenakum je odobrena za uporabo v biocidnih proizvodih 14. vrste proizvodov kot rodenticid v skladu z Uredbo (EU) št. 528/2012.
This application was evaluated by the competent authority of Finland as the evaluating competent authority.
To vlogo je ocenil pristojni organ Finske, ki je bil pristojni ocenjevalni organ.
On 24 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of difenacoum to the Agency.
Pristojni ocenjevalni organ je 24. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve difenakuma.
According to that opinion, difenacoum meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council [3] to be classified as toxic for reproduction category 1B.
V skladu z navedenim mnenjem difenakum izpolnjuje merila iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3] za razvrstitev kot strupen za razmnoževanje iz kategorije 1B.
The substance also meets the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council [4] for being very persistent, bioaccumulative and toxic.
Ta snov izpolnjuje tudi merila iz Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [4] za snov, ki je zelo obstojna, bioakumulativna in strupena.
Difenacoum therefore meets the exclusion criteria set in points (c) and (e) of Article 5(1) of Regulation (EU) No 528/2012.
Difenakum zato izpolnjuje merili za izključitev, določeni v točkah (c) in (e) člena 5(1) Uredbe (EU) št. 528/2012.
In addition, the use of products containing difenacoum raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore difenacoum also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012.
Poleg tega uporaba proizvodov, ki vsebujejo difenakum, zbuja pomisleke zaradi primerov primarne in sekundarne zastrupitve, tudi ko se uporabijo omejevalni ukrepi za obvladovanje tveganja, zato difenakum prav tako izpolnjuje merilo za možno snov za zamenjavo v skladu s členom 10(1)(e) Uredbe (EU) št. 528/2012.
In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on difenacoum, including information on available substitutes.
V skladu s členom 10(3) Uredbe (EU) št. 528/2012 je Agencija organizirala javno posvetovanje, da bi zbrala ustrezne informacije o difenakumu, vključno z informacijami o razpoložljivih nadomestkih.
The contributions to the two abovementioned public consultations, as well as the information regarding the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission report on risk-mitigation measures for anticoagulant rodenticides [5], were discussed with Member States in the Standing Committee on Biocidal Products.
V okviru Stalnega odbora za biocidne pripravke so z državami članicami potekala posvetovanja o prispevkih k obema zgoraj omenjenima javnima posvetovanjema ter o informacijah glede razpoložljivih alternativ za antikoagulantne rodenticide iz Priloge 1 k poročilu Komisije o ukrepih za zmanjšanje tveganja za antikoagulantne rodenticide [5].
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, difenacoum is considered essential to ensure appropriate rodent control in support of those alternatives.
Ker uspešen nadzor glodalcev ne more temeljiti le na navedenih nekemičnih metodah kontrole ali preprečevanja, velja difenakum za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
As a consequence the use of difenacoum would be to prevent or control a serious danger to human and animal health in which rodents are involved.
Posledično bi se difenakum uporabljal za preprečevanje ali nadzor resne nevarnosti za zdravje ljudi in živali, ki jo povzročajo glodalci.
On the other hand, the risks to human health, animal health or the environment arising from use of products containing difenacoum can be mitigated if they are used according to certain specifications and conditions.
Po drugi strani pa se tveganje za zdravje ljudi, zdravje živali oziroma okolje, ki izhaja iz uporabe proizvodov, ki vsebujejo difenakum, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
Therefore, the non-approval of difenacoum as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance.
Zato bi imela neodobritev difenakuma kot aktivne snovi nesorazmeren negativen učinek na družbo v primerjavi s tveganjem, ki izhaja iz uporabe snovi.
It is therefore appropriate to renew the approval of difenacoum for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Zato je primerno obnoviti odobritev difenakuma za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
Difenacoum is a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set out in Article 10(4) of that Regulation should apply.
Difenakum je možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012, zato bi bilo treba uporabiti obdobje obnovitve iz člena 10(4) navedene uredbe.
As the examination of the applications for the renewal of those approvals is now finalised, it is appropriate to repeal Implementing Decision 2014/397/EU.
SPREJELA NASLEDNJO UREDBO:
HAS ADOPTED THIS REGULATION:
Odobritev difenakuma kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
The approval of difenacoum as an active substance for use in biocidal products of product-type 14 is renewed, subject to the specifications and conditions set out in the Annex.
Izvedbeni sklep 2014/397/EU se razveljavi.
Implementing Decision 2014/397/EU is repealed.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Evropska komisija (2014), Bruselj, Belgija.
Risk mitigation measures for anticoagulant rodenticides — Final Report.
100 str.
100 pp.
Izvedbeni sklep Komisije 2014/397/EU z dne 25. junija 2014 o odložitvi datuma izteka odobritve difetialona in difenakuma za uporabo v biocidnih proizvodih za uporabo v vrsti proizvodov 14 (UL L 186, 26.6.2014, str. 111).
Commission Implementing Decision 2014/397/EU of 25 June 2014 postponing the expiry date of approval of difethialone and difenacoum for use in biocidal products for product-type 14 (OJ L 186, 26.6.2014, p. 111).
Splošno ime
Product type
difenakum
Difenacoum
3-(3-bifenil-4-il-1,2,3,4-tetrahidro-1-naftil)-4-hidroksikumarin
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin
ES: 259-978-4
EC No: 259-978-4
Št.
CAS No: 56073-07-5
CAS: 56073-07-5
Sum of isomers in a ratio of 50 %-80 % cis and 20 %-50 % trans isomers
Vsota izomerov v razmerju 50–80 % cis- in 20–50 % trans-izomerov
Difenacoum is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
Difenakum se šteje kot možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
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, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.
Poleg tega v skladu s točko 10 Priloge VI k Uredbi (EU) št. 528/2012 ocena proizvoda vključuje presojo, ali se lahko izpolnijo pogoji iz člena 5(2) Uredbe (EU) št. 528/2012.
Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied.
Proizvodi se odobrijo za uporabo samo v tistih državah članicah, kjer je izpolnjen vsaj eden od pogojev iz člena 5(2) Uredbe (EU) št. 528/2012.
The nominal concentration of difenacoum in the products shall not exceed 75 mg/kg.
Nominalna koncentracija difenakuma v proizvodih ne presega 75 mg/kg.
Primary as well as 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, for example, the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.
Ti ukrepi na primer vključujejo omejitev na uporabo s strani poklicnih ali usposobljenih poklicnih uporabnikov (če je mogoče) ter določitev dodatnih posebnih pogojev za posamezne kategorije uporabnikov.
for products against mice only:
samo za proizvode za zatiranje miši:
for grain, pellet or paste baits: 50 g;
za vabe v obliki zrn, peletov ali paste: 50 g;
for wax block baits: 100 g;
za vabe v obliki voščenega bloka: 100 g;
for products against rats only, or mice and rats:
samo za proizvode za zatiranje podgan oziroma podgan in miši:
for grain, pellet or paste baits: 150 g;
za vabe v obliki zrn, peletov ali paste: 150 g;
for wax block baits: 300 g.
za vabe v obliki voščenega bloka: 300 g.
Products shall not be authorised for use in pulse baiting treatments.
Proizvodi se ne odobrijo za uporabo pri pulznem nastavljanju vab.
Products may only be authorised for use in permanent baiting treatments at those sites with a high potential for reinvasion when other methods of control have proven insufficient.
Proizvodi se lahko odobrijo za uporabo pri stalnem nastavljanju vab samo na krajih z veliko možnostjo ponovne invazije, če se druge metode nadzora izkažejo kot neučinkovite.
Commission Implementing Regulation (EU) 2017/1380
Izvedbena uredba Komisije (EU) 2017/1380
renewing the approval of bromadiolone as an active substance for use in biocidal products of product-type 14
o obnovitvi odobritve bromadiolona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov
The active substance bromadiolone is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.
Aktivna snov bromadiolon je odobrena za uporabo v biocidnih proizvodih 14. vrste proizvodov kot rodenticid v skladu z Uredbo (EU) št. 528/2012.
In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application was submitted to the European Chemicals Agency ('the Agency') for the renewal of the approval of that active substance.
V skladu s členom 13(1) Uredbe (EU) št. 528/2012 je bila pri Evropski agenciji za kemikalije (v nadaljnjem besedilu: Agencija) vložena vloga za obnovitev odobritve navedene aktivne snovi.
This application was evaluated by the competent authority of Italy as the evaluating competent authority.
To vlogo je ocenil pristojni organ Italije, ki je bil pristojni ocenjevalni organ.
On 25 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of bromadiolone to the Agency.
Pristojni ocenjevalni organ je 25. marca 2016 Agenciji predložil priporočilo za obnovitev odobritve bromadiolona.
According to that opinion, bromadiolone meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council [3] to be classified as toxic for reproduction category 1B.
V skladu z navedenim mnenjem bromadiolon izpolnjuje merila iz Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3] za razvrstitev kot strupen za razmnoževanje iz kategorije 1B.
The substance also meets the criteria in Regulation (EC) No 1907/2006 of the European Parliament and of the Council [4] for being persistent, bioaccumulative and toxic.
Ta snov izpolnjuje tudi merila iz Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [4] za snov, ki je obstojna, bioakumulativna in strupena.
Bromadiolone therefore meets the exclusion criteria set out in points (c) and (e) of Article 5(1) of Regulation (EU) No 528/2012.
Bromadiolon zato izpolnjuje merili za izključitev, določeni v točkah (c) in (e) člena 5(1) Uredbe (EU) št. 528/2012.
In addition, the use of products containing bromadiolone raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore bromadiolone also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012.
Poleg tega uporaba proizvodov, ki vsebujejo bromadiolon, zbuja pomisleke zaradi primerov primarne in sekundarne zastrupitve, tudi ko se uporabijo omejevalni ukrepi za obvladovanje tveganja, zato bromadiolon prav tako izpolnjuje merilo za možno snov za zamenjavo v skladu s členom 10(1)(e) Uredbe (EU) št. 528/2012.
In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on bromadiolone, including information on available substitutes.
V skladu s členom 10(3) Uredbe (EU) št. 528/2012 je Agencija organizirala javno posvetovanje, da bi zbrala ustrezne informacije o bromadiolonu, vključno z informacijami o razpoložljivih nadomestkih.
As effective rodent control cannot rely on those non-chemical controls or prevention methods only, bromadiolone is considered essential to ensure appropriate rodent control in support of those alternatives.
Ker uspešen nadzor glodalcev ne more temeljiti le na navedenih nekemičnih metodah kontrole ali preprečevanja, velja bromadiolon za bistveno snov pri zagotavljanju ustreznega nadzora glodalcev in kot dopolnilo navedenim alternativam.
As a consequence the use of bromadiolone would be to prevent or control a serious danger to human and animal health in which rodents are involved.
Posledično bi se bromadiolon uporabljal za preprečevanje ali nadzor resne nevarnosti za zdravje ljudi in živali, ki jo povzročajo glodalci.
Therefore, the condition set out in Article 5(2)(b) of Regulation (EU) No 528/2012 is satisfied.
Zato je izpolnjen pogoj iz člena 5(2)(b) Uredbe (EU) št. 528/2012.
On the other hand, the risks to human health, animal health or the environment arising from use of products containing bromadiolone can be mitigated if they are used according to certain specifications and conditions.
Po drugi strani pa se tveganje za zdravje ljudi, zdravje živali oziroma okolje, ki izhaja iz uporabe proizvodov, ki vsebujejo bromadiolon, lahko zmanjša, če se ti proizvodi uporabljajo v skladu z določenimi specifikacijami in pogoji.
Therefore, the non-approval of bromadiolone as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance.
Zato bi imela neodobritev bromadiolona kot aktivne snovi nesorazmeren negativen učinek na družbo v primerjavi s tveganjem, ki izhaja iz uporabe snovi.
The condition set out in Article 5(2)(c) of Regulation (EU) No 528/2012 is thus also satisfied.
Zato je izpolnjen tudi pogoj iz člena 5(2)(c) Uredbe (EU) št. 528/2012.
It is therefore appropriate to renew the approval of bromadiolone for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.
Zato je primerno obnoviti odobritev bromadiolona za uporabo v biocidnih proizvodih 14. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
Bromadiolone is a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set out in Article 10(4) of that Regulation should apply.
Bromadiolon je možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012, zato bi bilo treba uporabiti obdobje obnovitve iz člena 10(4) navedene uredbe.
As the examination of the applications for the renewal of the approval of bromadiolone, chlorophacinone and coumatetralyl for use in biocidal products of product-type 14 is now finalised, Commission Implementing Decision (EU) 2015/1737 [6] is repealed by Implementing Regulation (EU) 2017/1377 [7].
Ker je proučitev vlog za obnovitev odobritev bromadiolona, klorofacinona in kumatetralila za uporabo v biocidnih proizvodih 14. vrste proizvodov zaključena, se Izvedbeni sklep Komisije (EU) 2015/1737 [6] razveljavi z Izvedbeno uredbo (EU) 2017/1377 [7].
The approval of bromadiolone as an active substance for use in biocidal products of product-type 14 is renewed, subject to the specifications and conditions set out in the Annex.
Odobritev bromadiolona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov se obnovi, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
100 pp.
100 str.
Commission Implementing Regulation (EU) 2017/1377 of 25 July 2017 renewing the approval of chlorophacinone as an active substance for use in biocidal products of product-type 14 (see page 15 of this Official Journal).
Izvedbena uredba Komisije (EU) 2017/1377 z dne 25. julija 2017 o obnovitvi odobritve bromadiolona kot aktivne snovi za uporabo v biocidnih proizvodih 14. vrste proizvodov (glej stran 15 tega Uradnega lista).
3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxycoumarin
3-[(1RS,3RS;1RS,3SR)-3-(4′-bromobifenil-4-il)-3-hidroksi-1-fenilpropil]-4-hidroksikumarin
EC No: 249-205-9
Št.
CAS No: 28772-56-7
ES: 249-205-9
Bromadiolone is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
CAS: 28772-56-7
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.
Bromadiolon se šteje kot možna snov za zamenjavo v skladu s točkama (a) in (e) člena 10(1) Uredbe (EU) št. 528/2012.
In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied;
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi splošnimi pogoji:
products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied;
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
the nominal concentration of bromadiolone in the products shall not exceed 50 mg/kg;
Poleg tega v skladu s točko 10 Priloge VI k Uredbi (EU) št. 528/2012 ocena proizvoda vključuje presojo, ali se lahko izpolnijo pogoji iz člena 5(2) Uredbe (EU) št. 528/2012.
products shall contain an aversive agent and a dye;
Proizvodi se odobrijo za uporabo samo v tistih državah članicah, kjer je izpolnjen vsaj eden od pogojev iz člena 5(2) Uredbe (EU) št. 528/2012.
products shall not be authorised in the form of tracking powder;
Nominalna koncentracija bromadiolona v proizvodih ne presega 50 mg/kg.
products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals;
Proizvodi vsebujejo averzivno sredstvo in barvilo.
only ready-to-use products shall be authorised;
Proizvodi se ne odobrijo v obliki sredstva za posipanje.
primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures.
Proizvodi v obliki kontaktnih pripravkov, ki niso sredstva za posipanje, se odobrijo samo za uporabo s strani usposobljenih poklicnih uporabnikov v zaprtih prostorih, nedostopnih otrokom ali neciljnim živalim.
These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category;
Odobrijo se samo proizvodi za takojšnjo uporabo.
dead bodies and uneaten bait shall be disposed of in accordance with local requirements.
Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
products shall only be authorised for use in tamper-resistant bait stations;
Metoda odstranjevanja je opisana posebej v povzetku značilnosti proizvoda v nacionalnih dovoljenjih in je omenjena na etiketi proizvoda.