natgillin/translations-raw huggingface dataset:
Strains of micro-organisms carrying an acquired resistance to antimicrobial(s) shall not be used as feed additives, unless it can be demonstrated that resistance is a result of chromosomal mutation(s) and it is not transferable.
Sevi mikroorganizmov, ki so pridobili odpornost proti protimikrobnim sredstvom, se ne uporabljajo kot krmni dodatki, razen če se dokaže, da je odpornost posledica kromosomskih mutacij in ni prenosljiva.
Manufacturing process, including any specific processing procedures
Postopek izdelave, vključno s kakršnimi koli posebnimi predelovalnimi postopki
To define the critical points of the process that may have an influence on the purity of the active substance/agent(s) or additive a description of the manufacturing process shall be given.
Za opredelitev kritičnih točk postopka, ki lahko vplivajo na čistost aktivnih snovi/sredstev ali dodatka, se opiše postopek izdelave.
A material safety data sheet of chemicals used in the production process shall be provided.
Predloži se varnostni list za kemikalije, ki se uporabljajo v postopku proizvodnje.
Active substance(s)/agent(s)
Aktivne snovi/sredstva
A description of the production process (e.g. chemical synthesis, fermentation, cultivation, extraction from organic material or distillation) used in the preparation of the active substance(s)/agent(s) of the additive shall be submitted, if appropriate by way of a flowchart.
Predloži se opis postopka proizvodnje (npr. kemična sinteza, fermentacija, kultivacija, ekstrakcija iz organske snovi ali destilacija), ki se uporablja pri pripravi aktivnih snovi/sredstev dodatka, po potrebi kot prikaz delovnih postopkov.
The composition of the fermentation/cultivation media shall be provided.
Navede se sestava gojišč pri kultivaciji/fermentaciji.
Purification methods shall be thoroughly described.
Metode prečiščevanja se natančno opišejo.
For Genetically Modified Micro-organisms (GMMs), used as source of additives and grown under contained conditions, Council Directive 90/219/EC applies.
Za gensko spremenjene mikroorganizme (GSM), ki se uporabljajo kot vir dodatkov in se gojijo v zaprtih sistemih, se uporablja Direktiva Sveta 90/219/ES.
A description of fermentation processes (culture medium, fermentation condition and downstream processing of the fermentation products) shall be included.2.3.2. Additive
Vključi se opis postopkov fermentacije (umetno gojišče, pogoji fermentacije in postopek v zaključnem procesu za proizvode fermentacije).2.3.2 Dodatek
A detailed description of the manufacturing process of the additive shall be submitted.
Predloži se natančen opis postopka izdelave dodatka.
The key stages in the preparation of the additive including the point(s) of introduction of the active substance(s)/agent(s) and other components, and any subsequent processing steps affecting the additive preparation should be provided, if appropriate by means of a flowchart.
Navesti je treba ključne stopnje pri pripravi dodatka, vključno s točkami vnosa aktivnih snovi/sredstev in drugih sestavin ter kakršnimi koli naslednjimi stopnjami predelave, ki vplivajo na pripravek iz dodatka, po potrebi kot prikaz delovnih postopkov.
Physico-chemical and technological properties of the additive
Fizikalno-kemijske in tehnološke lastnosti dodatka
Stability is generally measured by the analytical follow-up of the active substance(s)/agent(s) or its activity/viability.
Stabilnost se običajno meri z analitičnim spremljanjem aktivnih snovi/sredstev ali njihove aktivnosti/sposobnosti za preživetje.
For enzymes, stability may be defined in terms of loss of catalytic activity; for micro-organisms in terms of loss of viability; for flavouring substances in terms of loss of flavour.
Za encime se lahko stabilnost opredeli glede na izgubo katalitične aktivnosti; za mikroorganizme glede na izgubo sposobnosti za preživetje; za aromatične snovi glede na izgubo arome.
For other chemical mixtures/extracts stability may be assessed by monitoring the concentration of one or more appropriate marker substances.
Za druge mešanice/izvlečke kemikalij se lahko stabilnost oceni s spremljanjem koncentracije enega ali več ustreznih označevalcev.
Stability of the additive
Stabilnost dodatka
The stability of each formulation of the additive, on exposure to different environmental conditions (light, temperature, pH, moisture, oxygen and packing material) shall be studied.
Prouči se stabilnost vsake formulacije dodatka ob izpostavljenosti različnim okoljskim razmeram (svetloba, temperatura, pH, vlaga, kisik in embalaža).
For additives used in premixtures and in feedingstuffs, with the exception of flavouring compounds, the stability of each formulation of the additive shall be studied under common manufacturing and storage conditions of premixtures and of feedingstuffs.
Za dodatke, ki se uporabljajo v premiksih in krmi, razen aromatičnih snovi, se stabilnost vsake formulacije dodatka prouči pod splošnimi pogoji izdelave in skladiščenja premiksov in krme.
Stability studies in premixtures shall be of least six months' duration.
Študije stabilnosti za premikse trajajo najmanj šest mesecev.
Stability shall be tested preferably with premixtures containing trace elements; otherwise the additive should be labelled as ‘not to be mixed with trace elements’.
Stabilnost se po možnosti preskusi s premiksi, ki vsebujejo elemente v sledeh; v nasprotnem primeru je treba dodatek označiti kot „se ne sme mešati z elementi v sledeh“.
Stability studies in feedingstuffs normally shall extend at least for three months.
Študije stabilnosti za krmo običajno trajajo najmanj tri mesece.
Generally stability shall be checked in mash and pelleted (including the influence of pelleting or other forms of treatment) feed for the main animal species of the claim.
Na splošno se stabilnost preveri v vlažni in peletirani (vključno z vplivom peletiranja ali drugih vrst obdelave) krmi za glavne živalske vrste iz zahteve.
For additives intended to be used in water, the stability of each formulation of the additive has to be studied in water under condition simulating practical use.
Za dodatke, namenjene za uporabo v vodi, je treba stabilnost vsake formulacije dodatka proučiti v vodi pod pogoji, ki simulirajo praktično uporabo.
Where there is a loss of stability, and where appropriate, potential degradation or decomposition products shall be characterised.
Kadar pride do izgube stabilnosti in kadar je to primerno, se opišejo možni proizvodi razgrajevanja ali razpadanja.
Data shall be provided from analyses that include at least one observation at the beginning and one at the end of the storage period.
Predložijo se podatki analiz, ki vključujejo najmanj eno opazovanje na začetku in eno opazovanje na koncu obdobja skladiščenja.
Where necessary, studies shall contain the detailed quantitative and qualitative composition of the premixtures or of the feedingstuffs used for the trials.
Študije vključujejo po potrebi natančno količinsko in kakovostno sestavo premiksov ali krme, ki se uporablja pri preskusih.
The capacity for homogeneous distribution of the feed additive (other than flavouring compounds) in premixtures, feedingstuffs or water must be demonstrated.
Dokazati je treba sposobnost homogene porazdelitve krmnega dodatka (razen aromatičnih snovi) v premiksih, krmi ali vodi.
Other characteristics, such as dusting potential, electrostatic properties or dispersability in liquids must be described.
Opisati je treba druge lastnosti, kot so prašnost, elektrostatične lastnosti ali razpršljivost v tekočinah.
Physico-chemical incompatibilities or interactions
Fizikalno-kemijska nezdružljivost ali medsebojni vpliv
Physico-chemical incompatibilities or interactions that could be expected with feed, carriers, other approved additives, or medicinal products must be shown.
Pokazati je treba fizikalno-kemijsko nezdružljivost ali medsebojni vpliv, ki ga je mogoče pričakovati s krmo, nosilnimi snovmi, drugimi odobrenimi dodatki ali medicinskimi proizvodi.
Conditions of use of the additive
Pogoji uporabe dodatka
Proposed mode of use in animal nutrition
Predlagani način uporabe v prehrani živali
The animal species or categories, age group or production stage of animals shall be indicated in accordance with the categories listed in Annex IV of this Regulation.
Navedejo se živalske vrste ali kategorije, starostna skupina ali proizvodna stopnja živali v skladu s kategorijami iz Priloge IV k tej uredbi.
Possible contra-indications shall be mentioned.
Navedejo se možne kontraindikacije.
The proposed use, in feed or water shall be defined.
Opredeli se predlagana uporaba v krmi ali vodi.
Details of the proposed method of administration and level of inclusion must be provided for premixtures, feedingstuffs or water for drinking.
Zagotoviti je treba podatke o predlagani metodi dajanja in ravni vključevanja za premikse, krmo ali pitno vodo.
In addition, the proposed dose in the complete feed and the proposed duration of administration and proposed withdrawal period must be provided where appropriate.
Poleg tega je treba navesti predlagani odmerek v popolni krmni mešanici, predlagano trajanje dajanja in predlagano karenco, kadar je to primerno.
A justification is required where a particular use of an additive in complementary feedingstuffs is proposed.
Predložiti je treba utemeljitev, kadar se predlaga posebna uporaba dodatka v dopolnilni krmni mešanici.
Information related to users/workers safety
Informacije v zvezi z varnostjo uporabnikov/delavcev
A material safety data sheet formatted in accordance with the requirements of Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC must be provided.
Predložiti je treba varnostni list, oblikovan v skladu z zahtevami iz Direktive Komisije 91/155/EGS z dne 5. marca 1991 o opredelitvi in določitvi podrobne ureditve sistema posebnih informacij za nevarne pripravke pri izvajanju člena 10 Direktive 88/379/EGS.
If necessary, measures for the prevention of occupational risks and means of protection during manufacture, handling, use and disposal shall be proposed.2.5.2.2. Micro-organisms
Po potrebi se predlagajo ukrepi za preprečevanje poklicnih tveganj in sredstva zaščite med izdelavo, ravnanjem, uporabo in odstranitvijo.2.5.2.2 Mikroorganizmi
A classification according to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) shall be submitted.
Predloži se razvrstitev v skladu z Direktivo Evropskega parlamenta in Sveta 2000/54/ES z dne 18. septembra 2000 o varovanju delavcev pred tveganji zaradi izpostavljenosti biološkim dejavnikom pri delu (sedma posebna direktiva v smislu člena 16(1) Direktive 89/391/EGS).
For micro-organisms not classified in group 1 in this Directive, information shall be provided to customers to allow them to take the relevant protection measures for their workers, as defined in Article 3 (2) of the said Directive.2.5.2.3. Labelling requirements
Za mikroorganizme, ki niso razvrščeni v skupino 1 iz te direktive, se informacije zagotovijo potrošnikom, da lahko sprejmejo ustrezne varnostne ukrepe za svoje delavce, kakor je opredeljeno v členu 3(2) navedene direktive.2.5.2.3 Zahteve za označevanje
Without prejudice to the labelling and packaging provisions laid down in Article 16 of Regulation (EC) No 1831/2003, any specific labelling requirements and, where appropriate, specific conditions for use and handling (including known incompatibilities and contraindications) and instructions for proper use shall be indicated.
Brez poseganja v določbe o označevanju in pakiranju iz člena 16 Uredbe (ES) št. 1831/2003 se navedejo kakršne koli posebne zahteve za označevanje in po potrebi posebni pogoji uporabe in ravnanja (vključno z znano nezdružljivostjo in kontraindikacijami) ter navodila za pravilno uporabo.
Methods of analysis and reference samples
Analitske metode in referenčni vzorci
The methods of analysis shall be submitted in the standard layout as recommended by ISO (i.e. ISO 78-2).
Analitske metode se predložijo v standardni obliki, kot jo priporoča ISO (tj. ISO 78-2).
According to Regulation (EC) No 1831/2003 and Regulation (EC) No 378/2005, methods of analysis included in this section shall be evaluated by the CRL.
V skladu z Uredbo (ES) št. 1831/2003 in Uredbo (ES) št. 378/2005 analitske metode, vključene v ta oddelek, oceni referenčni laboratorij Skupnosti.
The CRL shall submit to the Authority an evaluation report indicating whether these methods are suitable to be used for official controls of the feed additive that is the object of the application.
Referenčni laboratorij Skupnosti predloži Agenciji ocenjevalno poročilo, v katerem je navedeno, ali so te metode ustrezne za uradni nadzor krmnega dodatka, ki je predmet vloge.
The CRL evaluation shall focus on the methods specified in sections 2.6.1 and 2.6.2.
Ocena referenčnega laboratorija Skupnosti obravnava zlasti metode iz oddelkov 2.6.1 in 2.6.2.
If an MRL has been established for the substance object of the application by Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, section 2.6.2 will not be subject to evaluation by the CRL.
Če je določen MRL za snov, ki je predmet vloge, v skladu z Uredbo Sveta (EGS) št. 2377/90 z dne 26. junija 1990 o določitvi postopka Skupnosti za določanje najvišjih mejnih vrednosti ostankov zdravil za uporabo v veterinarski medicini v živilih živalskega izvora, referenčni laboratorij Skupnosti ne oceni oddelka 2.6.2.
The applicant shall compile section 2.6.2 providing the same method, information and particulars (including relevant updates) for submission to European Medicines Agency (EMEA) in accordance with Annex V of Regulation (EEC) No 2377/90 and in accordance with ‘Notice to Applicants and Guidelines’, Volume 8 of the series ‘Rules governing medicinal products in the European Union’.
Vložnik pripravi oddelek 2.6.2, v katerem navede isto metodo, informacije in podatke (vključno z ustreznimi posodobitvami), za predložitev Evropski agenciji za zdravila (EMEA) v skladu s Prilogo V k Uredbi (EGS) št. 2377/90 in v skladu z zvezkom 8 „Obvestilo vložnikom in smernice“ serije „Pravila, ki urejajo zdravila v Evropski uniji“.
Analytical methods described under 2.6.3 may also be included in the evaluation, if considered necessary by the CRL, the Authority or the Commission.
V oceno se lahko vključijo tudi analitske metode, opisane v oddelku 2.6.3, če referenčni laboratorij Skupnosti, Agencija ali Komisija meni, da je to potrebno.
In accordance with Regulation (EC) No 378/2005, the applicant shall provide reference samples directly to the CRL prior to the evaluation of the technical dossier, and replacement samples before the expiration date.
V skladu z Uredbo (ES) št. 378/2005 predloži vložnik referenčne vzorce neposredno referenčnemu laboratoriju Skupnosti pred oceno tehnične dokumentacije in nadomestne vzorce pred datumom izteka veljavnosti.
Applicants shall refer to the detailed guidance provided by the CRL in accordance with Article 12 of Regulation (EC) No 378/2005.
Vložniki se sklicujejo na podrobne smernice, ki jih zagotovi referenčni laboratorij Skupnosti v skladu s členom 12 Uredbe (ES) št. 378/2005.
Methods of analysis for the active substance
Analitske metode za aktivno snov
Detailed characterisation of the qualitative and, where applicable, quantitative analytical method(s) for determining compliance with maximum or minimum proposed levels of the active substance(s)/agent(s) in the additive, premixtures, feedingstuffs and, when appropriate, water, shall be provided.
Natančno se opišejo lastnosti kakovostnih in po potrebi količinskih analitskih metod za določitev skladnosti z največjimi ali najmanjšimi predlaganimi količinami aktivnih snovi/sredstev v dodatku, premiksih, krmi in po potrebi v vodi.
These methods shall meet the same requirements as those for methods of analysis used for official control purpose laid down in Article 11 of Regulation (EC) No 882/2004 In particular they shall meet at least one of the following requirements:
Te metode izpolnjujejo enake zahteve, kot veljajo za analitske metode, ki se uporabljajo za uradni nadzor, iz člena 11 Uredbe (ES) št. 882/2004. Zlasti izpolnjujejo vsaj eno izmed naslednjih zahtev:
comply with relevant Community rules (e.g. Community methods of analysis) where they exist;
so v skladu z ustreznimi pravili Skupnosti (npr. metode analize Skupnosti), kadar obstajajo,
comply with internationally recognised rules or protocols, for example those that the European Committee for Standardisation (CEN) has accepted, or those agreed in national legislation (e.g. CEN Standard methods);
so v skladu z mednarodno priznanimi pravili ali protokoli, na primer pravili, ki jih je sprejel Evropski odbor za standardizacijo (CEN), ali pravili, dogovorjenimi v nacionalni zakonodaji (npr. metode po standardih CEN),
are fit for the intended purpose, developed in accordance with scientific protocols and validated in a ring test in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 or IUPAC); or
so primerne za predvideni namen, razvite v skladu z znanstvenimi protokoli in potrjene s testom primerljivosti v skladu z mednarodno priznanim protokolom o medlaboratorijskem preskušanju (npr. ISO 5725 ali IUPAC), ali
are validated in-house according to international harmonised guidelines for the in-house validation of methods of analysis with respect to the characterising parameters mentioned in 2.6.1.2.
so notranje potrjene v skladu z mednarodnimi usklajenimi smernicami za notranjo potrditev analitskih metod ob upoštevanju značilnih parametrov iz oddelka 2.6.1.2.
The detailed characterisation of the method(s) shall include the appropriate characteristics set out in Annex III of Regulation (EC) No 882/2004.
Natančen opis lastnosti metod vključuje ustrezne lastnosti iz Priloge III k Uredbi (ES) št. 882/2004.
Performance characteristics of in-house validated methods shall be verified by testing the method in a second, accredited and independent laboratory.
Delovne lastnosti notranje potrjenih metod se preverijo s preskusom metode v drugem akreditiranem in neodvisnem laboratoriju.
Results of such tests shall be provided together with any other information supporting the transferability of the method to an official control laboratory.
Rezultati takšnih preskusov se predložijo skupaj s kakršnimi koli drugimi informacijami, ki potrjujejo prenosljivost metode v laboratorij za uradni nadzor.
For reasons of independence and involvement in the evaluation of the documentation provided by the applicant, where the second laboratory is a laboratory participating in the consortium of National Reference Laboratories (NRLs) assisting the CRL, as laid down in Regulation (EC) No 378/2005, the laboratory shall send a declaration of interests to the CRL, as soon as the application is received by the CRL, describing the work of the laboratory in the application and shall not participate in the evaluation of the application.
Zaradi neodvisnosti in sodelovanja pri oceni dokumentov, ki jih predloži vložnik, kadar drugi laboratorij sodeluje v konzorciju nacionalnih referenčnih laboratorijev (NRL), ki pomaga referenčnemu laboratoriju Skupnosti, kakor je določeno v Uredbi (ES) št. 378/2005, laboratorij pošlje izjavo o interesih referenčnemu laboratoriju Skupnosti, takoj ko referenčni laboratorij Skupnosti prejme vlogo, pri čemer opiše delo laboratorija v vlogi, in ne sodeluje pri ocenjevanju vloge.
The CRL may select appropriate characteristics as mentioned under Annex III of Regulation (EC) No 882/2004 in its evaluation report to the Authority.
Referenčni laboratorij Skupnosti lahko v ocenjevalnem poročilu za Agencijo izbere ustrezne lastnosti iz Priloge III k Uredbi (ES) št. 882/2004.
Performance criteria for methods for specific groups of substances (e.g. enzymes) may be established in the detailed guidance provided by the CRL in accordance with Article 12 of Regulation (EC) No 378/2005.
Delovna merila za metode za posebne skupine snovi (npr. encime) se lahko določijo v podrobnih smernicah, ki jih pripravi referenčni laboratorij Skupnosti v skladu s členom 12 Uredbe (ES) št. 378/2005.
Methods of analysis for the determination of the residues of the additive or of its metabolites in food
Analitske metode za določitev ostankov dodatka ali njegovih metabolitov v hrani
Detailed characterisation of the qualitative and quantitative analytical method(s) for determining the marker residues and/or metabolites of the additive in target tissues and animal products shall be provided.
Natančno se opišejo lastnosti kakovostnih in količinskih analitskih metod za določitev ostankov označevalca in/ali metabolitov dodatka v ciljnih tkivih in proizvodih živalskega izvora.
These methods shall meet the same requirements as those for methods of analysis used for official control purposes as laid down in Article 11 of Regulation (EC) No 882/2004.
Te metode izpolnjujejo enake zahteve, kot veljajo za analitske metode, ki se uporabljajo za uradni nadzor, iz člena 11 Uredbe (ES) št. 882/2004.
In particular, the methods shall meet at least one of the requirements mentioned in 2.6.1.1.
Metode zlasti izpolnjujejo vsaj eno izmed zahtev iz oddelka 2.6.1.1.
The detailed characterisation of the method(s) shall include the appropriate characteristics as set out in Annex III of Regulation (EC) No 882/2004 and shall take into account the requirements set out in Commission Decision 2002/657/EC.
Natančen opis lastnosti metod vključuje ustrezne lastnosti iz Priloge III k Uredbi (ES) št. 882/2004 in upošteva zahteve iz Odločbe Komisije 2002/657/ES.
The same performance criteria laid down in Commission Decisions laying down analytical methods to be used for detecting certain substances and residues thereof in live animal products according to Council Directive 96/23/EC shall be considered where appropriate.
Upoštevajo se enaka delovna merila iz odločb Komisije o določitvi analitskih metod za odkrivanje nekaterih snovi in njihovih ostankov v živih živali v skladu z Direktivo Sveta 96/23/ES, kadar je to primerno.
The limit of quantification (LOQ) for each method must not exceed half of the corresponding MRL and must be validated across a range at least from one-half to two times the MRL.
Meja določljivosti (LOQ) za vsako metodo ne sme preseči polovice ustreznega MRL in mora biti potrjena v razponu od najmanj polovice do dvakratnika MRL.
Results of such tests shall be provided.
Predložijo se rezultati takšnih preskusov.
The CRL may select appropriate characteristics from the ones mentioned under point 2.6.2.2 in its evaluation report to the Authority.
Referenčni laboratorij Skupnosti lahko v ocenjevalnem poročilu za Agencijo izbere ustrezne lastnosti izmed lastnosti iz oddelka 2.6.2.2.
Methods of the analysis relating to the identity and characterisation of the additive
Analitske metode v zvezi z identiteto in opisom lastnosti dodatka
A description of the methods used for the determination of the characteristics listed under points 2.1.3, 2.1.4, 2.1.5, 2.2.2, 2.4.1, 2.4.2, 2.4.3, and 2.4.4 shall be provided by the applicant.
Vložnik predloži opis metod, ki se uporabljajo za določitev lastnosti iz točk 2.1.3, 2.1.4, 2.1.5, 2.2.2, 2.4.1, 2.4.2, 2.4.3 in 2.4.4.
In accordance with Annex II of Regulation (EC) No 1831/2003 as amended by Regulation (EC) No 378/2005, the methods submitted under this section may also be evaluated if considered relevant by the, the Authority or the Commission for the assessment of the application.
V skladu s Prilogo II k Uredbi (ES) št. 1831/2003, kakor je bila spremenjena z Uredbo (ES) št. 378/2005, se lahko ocenijo tudi metode, predložene v skladu s tem oddelkom, če referenčni laboratorij Skupnosti, Agencija ali Komisija meni, da so pomembne za oceno vloge.
It is recommended that the methods described under this section are internationally recognised.
Priporočljivo je, da so metode, opisane v skladu s tem oddelkom, mednarodno priznane.