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| source | target |
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| Izvedbena uredba Komisije (EU) št. 990/2012 | Commission Implementing Regulation (EU) No 990/2012 |
| z dne 25. oktobra 2012 | of 25 October 2012 |
| o izdaji dovoljenja za pripravek iz Propionibacterium acidipropionici (CNCM MA 26/4U) kot krmni dodatek za vse živalske vrste | concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) as a feed additive for all animal species |
| (Besedilo velja za EGP) | (Text with EEA relevance) |
| EVROPSKA KOMISIJA JE – | THE EUROPEAN COMMISSION, |
| ob upoštevanju Pogodbe o delovanju Evropske unije, | Having regard to the Treaty on the Functioning of the European Union, |
| ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1]in zlasti člena 9(2) Uredbe, | Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular Article 9(2) thereof, |
| ob upoštevanju naslednjega: | Whereas: |
| Uredba (ES) št. 1831/2003 določa izdajo dovoljenj za dodatke za uporabo v prehrani živali ter razloge in postopke za izdajo takih dovoljenj. | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| Člen 10(7) Uredbe (ES) št. 1831/2003 v povezavi s členom 10(1) do (4) navedene uredbe določa posebne določbe za vrednotenje proizvodov, ki se v Uniji uporabljajo kot silirni dodatki na datum začetka veljavnosti navedene uredbe. | Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives at the date that Regulation became applicable. |
| V skladu s členom 10(1) Uredbe (ES) št. 1831/2003 je bil pripravek Propionibacterium acidipropionici (CNCM MA 26/4U) (v nadaljnjem besedilu: pripravek) vpisan v register krmnih dodatkov Skupnosti kot obstoječ proizvod iz funkcionalne skupine silirnih dodatkov za vse živalske vrste. | In accordance with Article 10(1) of Regulation (EC) No 1831/2003, a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U), hereinafter ‘the preparation’, was entered in the Community Register of Feed Additives as an existing product belonging to the functional group of silage additives, for all animal species. |
| V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe je bil vložen zahtevek za dovoljenje za pripravek kot krmni dodatek za vse živalske vrste ter za njegovo uvrstitev v kategorijo „tehnoloških dodatkov“ in funkcionalno skupino „silirnih dodatkov“. | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation as a feed additive for all animal species, requesting that additive to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’. |
| V skladu s členom 7(3) Uredbe (ES) št. 1831/2003 so bili navedenemu zahtevku priloženi zahtevani podatki in dokumenti. | That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| (4) Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 25. aprila 2012 [2]navedla, da pripravek v predlaganih pogojih uporabe nima škodljivega vpliva na zdravje živali, ljudi ali na okolje in da lahko uporaba pripravka izboljša aerobno stabilnost obdelane silaže. | The European Food Safety Authority (the Authority) concluded in its opinion of 25 April 2012 [2]that, under the proposed conditions of use, the preparation does not have an adverse effect on animal health, human health or the environment, and that the use of the preparation has the potential to improve the aerobic stability of the treated silage. |
| Agencija meni, da ni potrebe po posebnih zahtevah v zvezi s poprodajnim nadzorom. | The Authority does not consider that there is a need for specific requirements of post-market monitoring. |
| Potrdila je tudi poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij Skupnosti, ustanovljen z Uredbo (ES) št. 1831/2003. | It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| Ocena pripravka je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni. | The assessment of the preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. |
| Zato je treba dovoliti uporabo pripravka, kakor je opredeljeno v Prilogi k tej uredbi. | Accordingly, the use of the preparation should be authorised as specified in the Annex to this Regulation. |
| Ker ni varnostnih razlogov, ki bi zahtevali takojšnje izvajanje spremenjenih pogojev za izdajo dovoljenja, je primerno, da se omogoči prehodno obdobje, da se lahko vse zainteresirane strani pripravijo na izpolnjevanje novih zahtev zaradi izdaje dovoljenja. | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali – | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| SPREJELA NASLEDNJO UREDBO: | HAS ADOPTED THIS REGULATION: |
| Člen 1 | Article 1 |
| Dovoljenje | Authorisation |
| Pripravek iz Priloge, ki spada v kategorijo dodatkov „tehnološki dodatki“ in funkcionalno skupino „silirni dodatki“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge. | The preparation specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. |
| Prehodni ukrepi | Transitional measures |
| Pripravek, ki je opredeljen v Prilogi, in krma, ki vsebuje navedeni pripravek, ki sta proizvedena in označena pred 15. majem 2013 v skladu s pravili, ki se uporabljajo pred 15. novembrom 2012, se lahko še naprej dajeta na trg in uporabljata do porabe obstoječih zalog. | The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 15 May 2013 in accordance with the rules applicable before 15 November 2012 may continue to be placed on the market and used until the existing stocks are exhausted. |
| Začetek veljavnosti | Entry into force |
| 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. |
| Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah. | This Regulation shall be binding in its entirety and directly applicable in all Member States. |
| V Bruslju, 25. oktobra 2012 | Done at Brussels, 25 October 2012. |
| UL L 268, 18.10.2003, str. 29. | OJ L 268, 18.10.2003, p. 29. |
| EFSA Journal 2012, 10(5):2673. | EFSA Journal 2012; 10(5):2673. |
| PRILOGA | ANNEX |
| Identifikacijska številka dodatka | Identification number of the additive |
| Ime imetnika dovoljenja | Name of the holder of authorisation |
| Dodatek | Additive |
| Sestava, kemijska formula, opis, analitska metoda | Composition, chemical formula, description, analytical method |
| Vrsta ali kategorija živali | Species or category of animal |
| Najvišja starost | Maximum age |
| Najnižja vsebnost | Minimum content |
| Najvišja vsebnost | Maximum content |
| Druge določbe | Other provisions |
| Datum poteka veljavnosti dovoljenja | End of period of authorisation |
| CFU/kg sveže snovi | CFU/kg of fresh material |
| Kategorija tehnoloških dodatkov. | Category of technological additives. |
| Funkcionalna skupina: silirni dodatki | Functional group: silage additives |
| Sestava dodatka | Additive composition |
| Pripravek iz Propionibacterium acidipropionici (CNCM MA 26/4U) z najnižjo vsebnostjo 1x108 CFU/g dodatka | Preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) containing a minimum of 1 x 108 CFU/g additive |
| Lastnosti aktivne snovi | Characterisation of the active substance |
| Analitska metoda [1]Metoda štetja pri krmnem dodatku: metoda razmaza na plošči (EN 15787). | Analytical method [1]Enumeration in the feed additive: spread plate method (EN 15787) |
| Identifikacija: gelska elektroforeza v utripajočem polju (PFGE). | Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| vse živalske vrste | All animal species |
| V navodilih za uporabo dodatka in premiksa je treba navesti temperaturo skladiščenja in rok trajanja. | In the directions for use of the additive and premixture, indicate the storage temperature and storage life. |
| Najnižji odmerek dodatka, kadar se ne uporablja v kombinaciji z drugimi mikroorganizmi kot silirnimi dodatki: 1x108 CFU/kg sveže snovi. | Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additive: 1 x 108 CFU/kg of fresh material. |
| Zaradi varnosti se pri ravnanju priporoča uporaba zaščite za dihala in rokavic. | For safety: it is recommended to use breathing protection and gloves during handling. |
| 15. november 2022 | 15 November 2022 |
| Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx. | Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx |
| o izdaji dovoljenja za cinkov klorid hidroksid monohidrat kot krmni dodatek za vse živalske vrste | concerning the authorisation of zinc chloride hydroxide monohydrate as feed additive for all animal species |
| ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1], zlasti člena 9(2) Uredbe, | Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular Article 9(2) thereof, |
| V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za dovoljenje za cinkov klorid hidroksid monohidrat. | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of zinc chloride hydroxide monohydrate. |
| Zahtevek zadeva dovoljenje za cinkov klorid hidroksid monohidrat kot krmni dodatek za vse živalske vrste in njegovo uvrstitev v kategorijo dodatkov „nutritivni dodatki“. | The application concerns the authorisation of zinc chloride hydroxide monohydrate as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’. |
| (4) Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v mnenju z dne 26. aprila 2012 [2]navedla, da cinkov klorid hidroksid monohidrat v predlaganih pogojih uporabe nima škodljivega vpliva na zdravje živali in ljudi ali okolje ter da je lahko pomemben vir cinka za vse živalske vrste. | The European Food Safety Authority (the Authority) concluded in its opinion of 26 April 2012 [2]that, under the proposed conditions of use, zinc chloride hydroxide monohydrate does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an effective source of zinc for all animal species. |
| Potrdila pa je poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003. | It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| Ocena cinkovega klorid hidroksid monohidrata je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni. | The assessment of zinc chloride hydroxide monohydrate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. |
| Zato je treba dovoliti uporabo tega pripravka, kakor je opredeljeno v Prilogi k tej uredbi. | Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
| Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali – | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| Pripravek iz Priloge, ki spada v kategorijo dodatkov „nutritivni dodatki“ in funkcionalno skupino „spojine elementov v sledovih“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge. | The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. |
| Vsebnost elementa (Zn) v mg/kg popolne krmne mešanice z 12 % vsebnostjo vlage | Content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 % |
| Kategorija nutritivnih dodatkov. | Category of nutritional additives. |
| Funkcionalna skupina: spojine elementov v sledovih | Functional group: compounds of trace elements |
| Lastnosti dodatka | Characterisation of the additive |
| kemijska formula: Zn5 (OH)8 Cl2 · (H2O) | Chemical formula: Zn5 (OH)8 Cl2 · (H2O) |
| številka CAS: 12167-79-2 | CAS Number: 12167-79-2 |
| čistost: najmanj 84 % | Purity: min. 84 % |
| cinkov oksid: največ 9 % | Zinc oxide: max. 9 % |
| vsebnost cinka: najmanj 54 % | Zinc content: min. 54 % |
| delci<50 μm: pod 1 % | Particles<50 μm: below 1 % |
| Analitska metoda [1]za identifikacijo kristalne oblike cinkovega klorid hidroksida v krmnem dodatku: | Analytical method [1]For the identification of zinc chloride hydroxide crystal form in the feed additive: |
| rentgenska difrakcija (XRD). | X-ray diffraction (XRD). |
| Za določanje skupnega cinka v dodatku in premiksih: | For the determination of total zinc in the additive and premixtures: |
| EN 15510: atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES) ali | EN 15510: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) or |
| CEN/TS 15621: atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES) po razklopu pod tlakom. | CEN/TS 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion. |
| Za določanje skupnega cinka v posamičnih krmilih in krmnih mešanicah: | For the determination of total zinc in feed materials and compound feed: |
| atomska absorpcijska spektrometrija (AAS) ali | Atomic Absorption Spectrometry (AAS) or |
| EN 15510 ali CEN/TS 15621. | EN 15510 or CEN/TS 15621. |
| hišne živali: 250 (skupaj) | Pets: 250 (total) |
| ribe: 200 (skupaj) | Fish: 200 (total) |
| druge vrste: 150 (skupaj) | Other species: 150 (total) |
| popolni in dopolnilni mlečni nadomestki: 200 (skupaj) | Complete and complementary milk replacers: 200 (total) |
| Za varnost uporabnika: Med ravnanjem je treba nositi zaščito za dihala ter zaščitna očala in rokavice. | For user safety: breathing protection, safety glasses and gloves should be worn during handling. |
| Dodatek se vključi v krmo v obliki premiksa. | The additive shall be incorporated into feed in the form of a premixture. |
| o določitvi standardnih uvoznih vrednosti za določitev uvozne cene za nekatere vrste sadja in zelenjave | establishing the standard import values for determining the entry price of certain fruit and vegetables |
| ob upoštevanju Uredbe Sveta (ES) št. 1234/2007 z dne 22. oktobra 2007 o vzpostavitvi skupne ureditve kmetijskih trgov in o posebnih določbah za nekatere kmetijske proizvode (Uredba o enotni SUT) [1], | Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [1], |
| ob upoštevanju Izvedbene uredbe Komisije (EU) št. 543/2011 z dne 7. junija 2011 o določitvi podrobnih pravil za uporabo Uredbe Sveta (ES) št. 1234/2007 za sektorja sadja in zelenjave ter predelanega sadja in zelenjave [2]ter zlasti člena 136(1) Uredbe, | Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors [2], and in particular Article 136(1) thereof, |
| Izvedbena uredba (EU) št. 543/2011 na podlagi izida večstranskih trgovinskih pogajanj urugvajskega kroga določa merila, po katerih Komisija določi standardne vrednosti za uvoz iz tretjih držav za proizvode in obdobja iz dela A Priloge XVI k tej uredbi. | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| Standardna uvozna vrednost se izračuna vsak delovni dan v skladu s členom 136(1) Izvedbene uredbe (EU) št. 543/2011 ob upoštevanju spremenljivih dnevnih podatkov. | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. |
| Zato bi morala ta uredba začeti veljati na dan objave v Uradnem listu Evropske unije – | Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| Standardne uvozne vrednosti iz člena 136 Izvedbene uredbe (EU) št. 543/2011 so določene v Prilogi k tej uredbi. | The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation. |
| Ta uredba začne veljati na dan objave v Uradnem listu Evropske unije. | This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. |
| UL L 299, 16.11.2007, str. 1. | OJ L 299, 16.11.2007, p. 1. |
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