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| source | target |
|---|---|
| Commission Implementing Regulation (EU) No 990/2012 | Regolament ta’ Implimentazzjoni tal-Kummissjoni (UE) Nru 990/2012 |
| of 25 October 2012 | tal-25 ta’ Ottubru 2012 |
| concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) as a feed additive for all animal species | dwar l-awtorizzazzjoni ta’ preparazzjoni ta’ Propionibacterium acidipropionici (CNCM MA 26/4U) bħala addittiv fl-għalf għall-ispeċijiet kollha tal-annimali |
| (Text with EEA relevance) | (Test b’relevanza għaż-ŻEE) |
| THE EUROPEAN COMMISSION, | IL-KUMMISSJONI EWROPEA, |
| Having regard to the Treaty on the Functioning of the European Union, | Wara li kkunsidrat it-Trattat dwar il-Funzjonament tal-Unjoni Ewropea, |
| 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, | Wara li kkunsidrat ir-Regolament (KE) Nru 1831/2003 tal-Parlament Ewropew u tal-Kunsill tat-22 ta’ Settembru 2003 dwar l-addittivi għall-użu fl-għalf tal-annimali [1], u b’mod partikolari l-Artikolu 9(2) tiegħu, |
| Whereas: | Billi: |
| 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. | Ir-Regolament (KE) Nru 1831/2003 jipprevedi l-awtorizzazzjoni ta’ addittivi għall-użu fin-nutriment tal-annimali u għar-raġunijiet u l-proċeduri għall-għoti ta’ awtorizzazzjoni bħal din. |
| 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. | L-Artikolu 10(7) tar-Regolament (KE) Nru 1831/2003 flimkien mal-Artikolu 10, minn (1) sa (4), tiegħu jistipula dispożizzjonijiet speċifiċi għall-evalwazzjoni tal-prodotti użati fl-Unjoni bħala addittivi tal-furrajna minn dakinhar li daħal fis-seħħ ir-Regolament. |
| 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. | Skont l-Artikolu 10(1) tar-Regolament (KE) Nru 1831/2003, preparazzjoni ta’ Propionibacterium acidipropionici (CNCM MA 26/4U), minn hawn ‘il quddiem “preparazzjoni”, ġiet irreġistrata fir-Reġistru Komunitarju tal-Addittivi fl-Għalf bħala prodott eżistenti li jappartjeni għall-grupp funzjonali ta’ addittivi tal-furrajna, għall-ispeċijiet kollha tal-annimali. |
| 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’. | Skont l-Artikolu 10(2) tar-Regolament (KE) Nru 1831/2003 flimkien mal-Artikolu 7 tiegħu, tressqet applikazzjoni għall-awtorizzazzjoni tal-preparazzjoni bħala addittiv fl-għalf għall-ispeċijiet tal-annimali kollha, bit-talba li l-addittiv jiġi kklassifikat fil-kategorija “addittivi teknoloġiċi” u fil-grupp funzjonali “addittivi tal-furrajna”. |
| That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. | Din l-applikazzjoni kienet akkumpanjata mid-dettalji u d-dokumenti meħtieġa skont l-Artikolu 7(3) tar-Regolament (KE) Nru 1831/2003. |
| 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. | L-Awtorità Ewropea dwar is-Sigurtà fl-Ikel (“l-Awtorità”) ikkonkludiet fl-opinjoni tagħha tal-25 ta’ April 2012 [2]li, skont il-kundizzjonijiet proposti tal-użu, il-preparazzjoni ma għandhiex effett negattiv fuq saħħet l-annimali, saħħet il-bniedem jew l-ambjent, u li l-użu tal-preparazzjoni għandha l-potenzjal li ttejjeb l-istabbiltà aerobika tal-furrajna ttrattata. |
| The Authority does not consider that there is a need for specific requirements of post-market monitoring. | L-Awtorità tqis li ma hemmx bżonn ta’ rekwiżiti speċifiċi ta’ monitoraġġ għal wara t-tqegħid fis-suq. |
| 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. | Hija vverifikat ukoll ir-rapport dwar il-metodu ta’ analiżi tal-addittiv tal-għalf fl-għalf imressaq mil-Laboratorju ta’ Referenza Komunitarju stabbilit permezz tar-Regolament (KE) Nru 1831/2003. |
| 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. | Il-valutazzjoni tal-preparazzjoni turi li l-kundizzjonijiet għall-awtorizzazzjoni, kif previsti fl-Artikolu 5 tar-Regolament (KE) Nru 1831/2003, huma ssodisfati. |
| Accordingly, the use of the preparation should be authorised as specified in the Annex to this Regulation. | Għaldaqstant, l-użu tal-preparazzjoni għandu jiġi awtorizzat kif speċifikat fl-Anness ta’ dan ir-Regolament. |
| 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. | Minħabba li r-raġunijiet ta’ sikurezza ma jeħtiġux l-applikazzjoni immedjata tal-modifiki fil-kundizzjonijiet tal-awtorizzazzjoni, huwa xieraq li jitħalla perjodu tranżitorju sabiex il-partijiet interessati jħejju ruħhom biex jilħqu r-rekwiżiti l-ġodda li jirriżultaw mill-awtorizzazzjoni. |
| The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, | Il-miżuri stipulati f’dan ir-Regolament huma skont l-opinjoni tal-Kumitat Permanenti dwaril-Katina Alimentari u s-Saħħa tal-Annimali, |
| HAS ADOPTED THIS REGULATION: | ADOTTAT DAN IR-REGOLAMENT: |
| Article 1 | Artikolu 1 |
| Authorisation | Awtorizzazzjoni |
| 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. | Il-preparazzjoni speċifikata fl-Anness, li tifforma parti mill-kategorija ta’ addittivi “addittivi teknoloġiċi” u mill-grupp funzjonali “addittivi tal-furrajna”, hija awtorizzata bħala addittiv fl-għalf tal-annimali, soġġetta għall-kundizzjonijiet stipulati f’dak l-Anness. |
| Transitional measures | Miżuri tranżitorji |
| 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. | Il-preparazzjoni speċifikata fl-Anness u l-għalf li fih dik il-preparazzjoni, li huma manifatturati u ttikkettjati qabel il-15 ta’ Mejju 2013 skont ir-regoli applikabbli qabel il-15 ta’ Novembru 2012 jistgħu jibqgħu jitqiegħdu fis-suq u jintużaw sakemm il-ħażniet eżistenti tagħhom jispiċċaw. |
| Entry into force | Dħul fis-seħħ |
| This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. | Dan ir-Regolament għandu jidħol fis-seħħ fl-20 jum wara l-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. |
| This Regulation shall be binding in its entirety and directly applicable in all Member States. | Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha. |
| Done at Brussels, 25 October 2012. | Magħmul fi Brussell, il-25 ta’ Ottubru 2012. |
| OJ L 268, 18.10.2003, p. 29. | ĠU L 268, 18.10.2003, p. 29. |
| EFSA Journal 2012; 10(5):2673. | EFSA Journal 2012;10(5):2673. |
| ANNEX | ANNESS |
| Identification number of the additive | Numru ta’ identifikazzjoni tal-addittiv |
| Name of the holder of authorisation | Isem id-detentur tal-awtorizzazzjoni |
| Additive | Addittiv |
| Composition, chemical formula, description, analytical method | Kompożizzjoni, formula kimika, deskrizzjoni, metodu analitiku |
| Species or category of animal | Speċi jew kategorija ta’ annimali |
| Maximum age | Età massima |
| Minimum content | Kontenut minimu |
| Maximum content | Kontenut massimu |
| Other provisions | Dispożizzjonijiet oħra |
| End of period of authorisation | Tmiem il-perjodu ta’ awtorizzazzjoni |
| CFU/kg of fresh material | CFU/kg ta’ materja friska |
| Category of technological additives. | Kategorija ta’ addittivi teknoloġiċi. |
| Functional group: silage additives | Grupp funzjonali: additivi tal-furrajna |
| Additive composition | Kompożizzjoni tal-addittiv |
| Preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) containing a minimum of 1 x 108 CFU/g additive | Preparazzjoni ta’ propionibacterium acidipropionici (CNCM MA 26/4U) li jkollha minimu ta’ addittiv ta’ 1 x 108 CFU/g |
| Characterisation of the active substance | Karatterizzazzjoni tas-sustanza attiva |
| Analytical method [1]Enumeration in the feed additive: spread plate method (EN 15787) | Metodu analitiku [1]Enumerazzjoni fl-addittiv tal-għalf: il-metodu tat-tifrix (EN 15787) |
| Identification: Pulsed Field Gel Electrophoresis (PFGE). | Identifikazzjoni: Elettroforeżi bil-Ġell f’Kamp Pulsat (PFGE). |
| All animal species | L-ispeċijiet kollha tal-annimali |
| In the directions for use of the additive and premixture, indicate the storage temperature and storage life. | Fl-istruzzjonijiet għall-użu tal-addittiv u t-taħlita lesta minn qabel, indika t-temperatura li fiha għandu jinħażen, u kemm jista’ jdum maħżun. |
| 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. | Id-doża minima tal-addittiv meta ma tintużax ma’ taħlita ta’ mikroorganiżmi oħrajn bħala addittivi tal-furrajna: 1 x 108 CFU/kg ta’ materja friska. |
| For safety: it is recommended to use breathing protection and gloves during handling. | Għas-sikurezza: huwa rakkomandat li tintuża protezzjoni għall-imnifsejn u par ingwanti waqt l-immaniġġjar. |
| 15 November 2022 | Il-15 ta’ Novembru 2022 |
| 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 | Id-dettalji dwar il-metodi analitiċi huma disponibbli fl-indirizz li ġej tal-Laboratorju ta’ Referenza: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx |
| concerning the authorisation of zinc chloride hydroxide monohydrate as feed additive for all animal species | dwar l-awtorizzazzjoni tal-idrossiklorur taż-żingu monoidrat bħala addittiv fl-għalf għall-ispeċi kollha tal-annimali |
| 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, | Wara li kkunsidrat ir-Regolament (KE) Nru 1831/2003 tal-Parlament Ewropew u tal-Kunsill tat-22 ta’ Settembru 2003 dwar l-addittivi għall-użu fin-nutriment tal-annimali [1], u b’mod partikolari l-Artikolu 9(2) tiegħu, |
| In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of zinc chloride hydroxide monohydrate. | F’konformità mal-Artikolu 7 tar-Regolament (KE) Nru 1831/2003, tressqet applikazzjoni għall-awtorizzazzjoni tal-idrossiklorur taż-żingu monoidrat. |
| That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. | Din l-applikazzjoni kienet akkumpanjata mill-partikolaritajiet u d-dokumenti meħtieġa skont l-Artikolu 7(3) tar-Regolament (KE) Nru 1831/2003. |
| 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’. | L-applikazzjoni tikkonċerna l-awtorizzazzjoni tal-idrossiklorur taż-żingu monoidrat bħala addittiv fl-għalf għall-ispeċijiet kollha tal-annimali, biex jiġi kklassifikat fil-kategorija tal-addittivi “addittivi nutrittivi”. |
| 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. | Fl-opinjoni tagħha tas-26 ta’ April 2012 [2], l-Awtorità Ewropea dwar is-Sigurtà fl-Ikel (“l-Awtorità”) kkonkludiet li skont il-kundizzjonijiet ta’ użu proposti, l-idrossiklorur taż-żingu monoidrat ma għandux effett avvers fuq is-saħħa tal-annimali, is-saħħa tal-bniedem jew l-ambjent u li l-użu tiegħu jista’ jitqies bħala sors effettiv ta’ żingu għall-ispeċijiet kollha tal-annimali. |
| The Authority does not consider that there is a need for specific requirements of post-market monitoring. | L-Awtorità tqis li ma hemmx bżonn ta’ rekwiżiti speċifiċi ta’ monitoraġġ għal wara il-kummerċjalizzazzjoni. |
| 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. | Hija vverifikat ukoll ir-rapport dwar il-metodu ta’ analiżi tal-addittiv tal-għalf fl-għalf imressaq mil-Laboratorju ta’ Referenza stabbilit mir-Regolament (KE) Nru 1831/2003. |
| 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. | Il-valutazzjoni tal-idrossiklorur taż-żingu monoidrat turi li l-kundizzjonijiet għall-awtorizzazzjoni, kif stipulati fl-Artikolu 5 tar-Regolament (KE) Nru 1831/2003, huma sodisfatti. |
| Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. | Għaldaqstant, l-użu ta’ din il-preparazzjoni għandu jiġi awtorizzat kif speċifikat fl-Anness ta’ dan ir-Regolament. |
| The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, | Il-miżuri stipulati f’dan ir-Regolament huma konformi mal-opinjoni tal-Kumitat Permanenti dwar il-Katina Alimentari u s-Saħħa tal-Annimali. |
| 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. | Il-preparazzjoni speċifikata fl-Anness, li tifforma parti mill-kategorija ta’ addittivi, “addittivi nutrittivi”, u mill-grupp funzjonali, “komposti ta’ mikroelementi”, hija awtorizzata bħala addittiv fin-nutrizzjoni tal-annimali, suġġetta għall-kundizzjonijiet stipulati fl-Anness. |
| This Regulation shall enter into force on the twentieth day following that of its publicationin the Official Journal of the European Union. | Dan ir-Regolament għandu jidħol fis-seħħ fl-20 jum ta’ wara l-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. |
| Other provisions | Dispożizzjonijet oħra |
| Content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 % | Kontenut tal-element (Zn) f’mg/kg ta’ għalf sħiħ b’kontenut ta’ umdità ta’ 12 % |
| Category of nutritional additives. | Kategorija ta’ addittivi nutrittivi. |
| Functional group: compounds of trace elements | Grupp funzjonali: komposti ta’ mikroelementi |
| zinc chloride hydroxide monohydrate | idrossiklorur taż-żingu monoidrat |
| Characterisation of the additive | Karatterizzazzjoni tal-addittiv |
| Chemical formula: Zn5 (OH)8 Cl2 · (H2O) | Formula Kimika Zn5 (OH)8 Cl2 · (H2O) |
| CAS Number: 12167-79-2 | Numru CAS: 12167-79-2 |
| Purity: min. 84 % | Purità: min. 84 % |
| Zinc oxide: max. 9 % | Ossidu taż-żingu: max 9 % |
| Zinc content: min. 54 % | Kontenut ta’ żingu: min. 54 % |
| Particles<50 μm: below 1 % | Partiċelli<50 μm: taħt il-1 % |
| Analytical method [1]For the identification of zinc chloride hydroxide crystal form in the feed additive: | Metodu analitiku [1]Għall-identifikazzjoni tal-forma kristallina idrossiklorur taż-żingu fl-addittiv tal-għalf: |
| X-ray diffraction (XRD). | Diffrazzjoni tar-Raġġi-X (XRD). |
| For the determination of total zinc in the additive and premixtures: | Għad-determinazzjoni tat-total taż-żingu fl-addittiv u fil-pretaħlitiet: |
| EN 15510: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) or | EN 15510: Plażma Abbinata b’mod Induttiv – Spettrometrija b’Emissjoni Atomika (ICP-AES), jew |
| CEN/TS 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion. | CEN/TS 15621: Plażma Abbinata b’mod Induttiv – Spettrometrija b’Emissjoni Atomika (ICP-AES), wara d-diġestjoni bi pressjoni. |
| For the determination of total zinc in feed materials and compound feed: | Għad-determinazzjoni tat-total taż-żingu fil-materjali tal-għalf u fl-għalf kompost: |
| Atomic Absorption Spectrometry (AAS) or | Spettrometrija tal-Assorbiment Atomiku (AAS); jew |
| EN 15510 or CEN/TS 15621. | EN 15510 jew CEN/TS 15621. |
| All animal species | L-ispeċi kollha tal-annimali |
| Pets: 250 (total) | Annimali domestiċi: 250 (totali) |
| Fish: 200 (total) | Ħut: 200 (totali) |
| Other species: 150 (total) | Speċi oħra: 150 (totali) |
| Complete and complementary milk replacers: 200 (total) | Sostituti tal-ħalib kompluti u komplementarji 200 (totali) |
| For user safety: breathing protection, safety glasses and gloves should be worn during handling. | Għas-sikurezza tal-utent: Għandhom jintlibsu protezzjoni għan-nifs, nuċċalijiet tas-sikurezza u ngwanti waqt l-użu. |
| The additive shall be incorporated into feed in the form of a premixture. | L-addittiv għandu jiġi inkorporat fl-għalf f’forma ta’ pretaħlita. |
| establishing the standard import values for determining the entry price of certain fruit and vegetables | li jistabbilixxi l-valuri standard tal-importazzjoni għad-determinazzjoni tal-prezz ta' dħul ta' ċertu frott u ħxejjex |
| 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], | Wara li kkunsidrat ir-Regolament tal-Kunsill (KE) Nru 1234/2007 tat-22 ta' Ottubru 2007 li jistabbilixxi organizzazzjoni komuni ta' swieq agrikoli u dwar dispożizzjonijiet speċifiċi għal ċerti prodotti agrikoli (Ir-Regolament Waħdieni dwar l-OKS) [1], |
| 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, | Wara li kkunsidrat ir-Regolament ta’ Implimentazzjoni (UE) Nru 543/2011 tas-7 ta’ Ġunju 2011 li jippreskrivi regoli dettaljati dwar l-applikazzjoni tar-Regolament tal-Kunsill (KE) Nru 1234/2007 fir-rigward tas-setturi tal-frott u l-ħxejjex u tal-frott u l-ħxejjex ipproċessati [2]u b’mod partikolari l-Artikolu 136(1) tiegħu, |
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