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This page contains the European Commission terminology glossary for the language pair Maltese to English. It is designed for translators, localization specialists and language professionals working with EU terminology and multilingual institutional texts.
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| source | target |
|---|---|
| Regolament ta’ Implimentazzjoni tal-Kummissjoni (UE) Nru 990/2012 | Commission Implementing Regulation (EU) No 990/2012 |
| tal-25 ta’ Ottubru 2012 | of 25 October 2012 |
| dwar l-awtorizzazzjoni ta’ preparazzjoni ta’ Propionibacterium acidipropionici (CNCM MA 26/4U) bħala addittiv fl-għalf għall-ispeċijiet kollha tal-annimali | concerning the authorisation of a preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) as a feed additive for all animal species |
| (Test b’relevanza għaż-ŻEE) | (Text with EEA relevance) |
| IL-KUMMISSJONI EWROPEA, | THE EUROPEAN COMMISSION, |
| Wara li kkunsidrat it-Trattat dwar il-Funzjonament tal-Unjoni Ewropea, | Having regard to the Treaty on the Functioning of the European Union, |
| 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, | 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, |
| Billi: | Whereas: |
| 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. | 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. |
| 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. | 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. |
| 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(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(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”. | 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’. |
| Din l-applikazzjoni kienet akkumpanjata mid-dettalji u d-dokumenti meħtieġa skont l-Artikolu 7(3) tar-Regolament (KE) Nru 1831/2003. | That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| 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 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 tqis li ma hemmx bżonn ta’ rekwiżiti speċifiċi ta’ monitoraġġ għal wara t-tqegħid fis-suq. | The Authority does not consider that there is a need for specific requirements of post-market monitoring. |
| 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. | 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. |
| Il-valutazzjoni tal-preparazzjoni turi li l-kundizzjonijiet għall-awtorizzazzjoni, kif previsti fl-Artikolu 5 tar-Regolament (KE) Nru 1831/2003, huma ssodisfati. | 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. |
| Għaldaqstant, l-użu tal-preparazzjoni għandu jiġi awtorizzat kif speċifikat fl-Anness ta’ dan ir-Regolament. | Accordingly, the use of the preparation should be authorised as specified in the Annex to this Regulation. |
| 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. | 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. |
| Il-miżuri stipulati f’dan ir-Regolament huma skont l-opinjoni tal-Kumitat Permanenti dwar il-Katina Alimentari u s-Saħħa tal-Annimali, | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| ADOTTAT DAN IR-REGOLAMENT: | HAS ADOPTED THIS REGULATION: |
| Artikolu 1 | Article 1 |
| Awtorizzazzjoni | Authorisation |
| 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. | 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. |
| Miżuri tranżitorji | Transitional measures |
| Il-preparazzjoni speċifikata fl-Annessu 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. | 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. |
| Dħul fis-seħħ | Entry into force |
| Dan ir-Regolament għandu jidħol fis-seħħ fl-20 jum wara l-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. | 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 jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha. | This Regulation shall be binding in its entirety and directly applicable in all Member States. |
| Magħmul fi Brussell, il-25 ta’ Ottubru 2012. | Done at Brussels, 25 October 2012. |
| ĠU L 268, 18.10.2003, p. 29. | OJ L 268, 18.10.2003, p. 29. |
| EFSA Journal 2012;10(5):2673. | EFSA Journal 2012; 10(5):2673. |
| ANNESS | ANNEX |
| Numru ta’ identifikazzjoni tal-addittiv | Identification number of the additive |
| Isem id-detentur tal-awtorizzazzjoni | Name of the holder of authorisation |
| Addittiv | Additive |
| Kompożizzjoni, formula kimika, deskrizzjoni, metodu analitiku | Composition, chemical formula, description, analytical method |
| Speċi jew kategorija ta’ annimali | Species or category of animal |
| Età massima | Maximum age |
| Kontenut minimu | Minimum content |
| Kontenut massimu | Maximum content |
| Dispożizzjonijiet oħra | Other provisions |
| Tmiem il-perjodu ta’ awtorizzazzjoni | End of period of authorisation |
| CFU/kg ta’ materja friska | CFU/kg of fresh material |
| Kategorija ta’ addittivi teknoloġiċi. | Category of technological additives. |
| Grupp funzjonali: additivi tal-furrajna | Functional group: silage additives |
| Kompożizzjoni tal-addittiv | Additive composition |
| Preparazzjoni ta’ propionibacterium acidipropionici (CNCM MA 26/4U) li jkollha minimu ta’ addittiv ta’ 1 x 108 CFU/g | Preparation of Propionibacterium acidipropionici (CNCM MA 26/4U) containing a minimum of 1 x 108 CFU/g additive |
| Karatterizzazzjoni tas-sustanza attiva | Characterisation of the active substance |
| Metodu analitiku [1]Enumerazzjoni fl-addittiv tal-għalf: il-metodu tat-tifrix (EN 15787) | Analytical method [1]Enumeration in the feed additive: spread plate method (EN 15787) |
| Identifikazzjoni: Elettroforeżi bil-Ġell f’Kamp Pulsat (PFGE). | Identification: Pulsed Field Gel Electrophoresis (PFGE). |
| L-ispeċijiet kollha tal-annimali | All animal species |
| Fl-istruzzjonijiet għall-użu tal-addittiv u t-taħlita lesta minn qabel, indika t-temperatura li fiha għandu jinħażen, u kemm jista’ jdum maħżun. | In the directions for use of the additive and premixture, indicate the storage temperature and storage life. |
| 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. | 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. |
| Għas-sikurezza: huwa rakkomandat li tintuża protezzjoni għall-imnifsejn u par ingwanti waqt l-immaniġġjar. | For safety: it is recommended to use breathing protection and gloves during handling. |
| Il-15 ta’ Novembru 2022 | 15 November 2022 |
| 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 | 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 |
| dwar l-awtorizzazzjoni tal-idrossiklorur taż-żingu monoidrat bħala addittiv fl-għalf għall-ispeċi kollha tal-annimali | concerning the authorisation of zinc chloride hydroxide monohydrate as feed additive for all animal species |
| 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, | Havingregard 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, |
| F’konformità mal-Artikolu 7 tar-Regolament (KE) Nru 1831/2003, tressqet applikazzjoni għall-awtorizzazzjoni tal-idrossiklorur taż-żingu monoidrat. | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of zinc chloride hydroxide monohydrate. |
| Din l-applikazzjoni kienet akkumpanjata mill-partikolaritajiet u d-dokumenti meħtieġa skont l-Artikolu 7(3) tar-Regolament (KE) Nru 1831/2003. | That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| 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 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’. |
| 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 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. |
| L-Awtorità tqis li ma hemmx bżonn ta’ rekwiżiti speċifiċi ta’ monitoraġġ għal wara il-kummerċjalizzazzjoni. | The Authority does not consider that there is a need for specific requirements of post-market monitoring. |
| 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. | 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. |
| 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. | 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. |
| Għaldaqstant, l-użu ta’ din il-preparazzjoni għandu jiġi awtorizzat kif speċifikat fl-Anness ta’ dan ir-Regolament. | Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation. |
| Il-miżuri stipulati f’dan ir-Regolament huma konformi mal-opinjoni tal-Kumitat Permanenti dwar il-Katina Alimentari u s-Saħħa tal-Annimali. | 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-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. | 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. |
| Dan ir-Regolament għandu jidħol fis-seħħ fl-20 jum ta’ wara l-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. | This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. |
| Dispożizzjonijet oħra | Other provisions |
| Kontenut tal-element (Zn) f’mg/kg ta’ għalf sħiħ b’kontenut ta’ umdità ta’ 12 % | Content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12 % |
| Kategorija ta’ addittivi nutrittivi. | Category of nutritional additives. |
| Grupp funzjonali: komposti ta’ mikroelementi | Functional group: compounds of trace elements |
| idrossiklorur taż-żingu monoidrat | zinc chloride hydroxide monohydrate |
| Karatterizzazzjoni tal-addittiv | Characterisation of the additive |
| Formula Kimika Zn5 (OH)8 Cl2 · (H2O) | Chemical formula: Zn5 (OH)8 Cl2 · (H2O) |
| Numru CAS: 12167-79-2 | CAS Number: 12167-79-2 |
| Purità: min. 84 % | Purity: min. 84 % |
| Ossidu taż-żingu: max 9 % | Zinc oxide: max. 9 % |
| Kontenut ta’ żingu: min. 54 % | Zinc content: min. 54 % |
| Partiċelli<50 μm: taħt il-1 % | Particles<50 μm: below 1 % |
| Metodu analitiku [1]Għall-identifikazzjoni tal-forma kristallina idrossiklorur taż-żingu fl-addittiv tal-għalf: | Analytical method [1]For the identification of zinc chloride hydroxide crystal form in the feed additive: |
| Diffrazzjoni tar-Raġġi-X (XRD). | X-ray diffraction (XRD). |
| Għad-determinazzjoni tat-total taż-żingu fl-addittiv u fil-pretaħlitiet: | For the determination of total zinc in the additive and premixtures: |
| EN 15510: Plażma Abbinata b’mod Induttiv – Spettrometrija b’Emissjoni Atomika (ICP-AES), jew | EN 15510: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) or |
| CEN/TS 15621: Plażma Abbinata b’mod Induttiv – Spettrometrija b’Emissjoni Atomika (ICP-AES), wara d-diġestjoni bi pressjoni. | CEN/TS 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion. |
| Għad-determinazzjoni tat-total taż-żingu fil-materjalital-għalf u fl-għalf kompost: | For the determination of total zinc in feed materials and compound feed: |
| Spettrometrija tal-Assorbiment Atomiku (AAS); jew | Atomic Absorption Spectrometry (AAS) or |
| EN 15510 jew CEN/TS 15621. | EN 15510 or CEN/TS 15621. |
| L-ispeċi kollha tal-annimali | All animal species |
| Annimali domestiċi: 250 (totali) | Pets: 250 (total) |
| Ħut: 200 (totali) | Fish: 200 (total) |
| Speċi oħra: 150 (totali) | Other species: 150 (total) |
| Sostituti tal-ħalib kompluti u komplementarji 200 (totali) | Complete and complementary milk replacers: 200 (total) |
| Għas-sikurezza tal-utent: Għandhom jintlibsu protezzjoni għan-nifs, nuċċalijiet tas-sikurezza u ngwanti waqt l-użu. | For user safety: breathing protection, safety glasses and gloves should be worn during handling. |
| L-addittiv għandu jiġi inkorporat fl-għalf f’forma ta’ pretaħlita. | The additive shall be incorporated into feed in the form of a premixture. |
| li jistabbilixxi l-valuri standard tal-importazzjoni għad-determinazzjoni tal-prezz ta' dħul ta' ċertu frott u ħxejjex | establishing the standard import values for determining the entry price of certain fruit and vegetables |
| 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 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 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, | 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, |
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