FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In addition, all relevant morphological, physiological and molecular characteristics necessary to provide the unique identification of the strain and the means to confirm its genetic stability shall be described. For GMOs the description of the genetic modifications shall be given.
Spanish: Se describirán, además, todas las características morfológicas, fisiológicas y moleculares pertinentes que sean necesarias para proporcionar la identificación única de la cepa y los medios para confirmar su estabilidad genética.
English: number of test and control groups, number of animals in each group: the number of animals involved in the trials must permit statistical analysis. The methods of statistical evaluation used should be stated. The report shall include all animals and/or experimental units involved in the trials. Cases which cannot be assessed due to a lack or loss of data shall be reported, and their distribution within the groups of animals classified;
Spanish: número de grupos experimentales y de referencia; número de animales en cada grupo: el número de animales que participan en los ensayos deberá permitir el análisis estadístico; deben declararse los métodos de evaluación estadística aplicados; en el informe se incluirán todos los animales o unidades experimentales que participen en los ensayos; se informará de los casos que no puedan evaluarse debido a la falta o la pérdida de datos, así como de su distribución en los grupos de animales clasificados;
English: TRCi-j
French: CRTi-j
Spanish: CTRi-j
Lithuanian: BLKi-j
English: MRCi-j
French: CRMi-j
Spanish: CRMi-j
Lithuanian: LŽKi-j
English: RMTRi-j
French: RRMTi-j
Spanish: RMRTi-j
Lithuanian: ŽBLSi-j
English: DITRi-j
French: AARTi-j
Spanish: IARTi-j
Lithuanian: MLBLi-j
English: RMTR [16]
French: RRMT [16]
Spanish: RMRT [16]
Lithuanian: ŽBLS [16]
English: DITR [17] (mg)
French: AART [17] (mg)
Spanish: IART [17] (mg)
Swedish: DITR [17] (i mg)
Lithuanian: MLBL [17] (mg)
English: the worst case Predicted Environmental Concentration (PEC) is too low to be of concern. The PEC shall be evaluated for each compartment of concern (see below), assuming that 100 % of the dose ingested is excreted as the parent compound.
Spanish: en el peor de los casos, la concentración ambiental prevista (PEC) es demasiado baja para resultar preocupante; la PEC deberá evaluarse en relación con cada compartimento de interés (véase más adelante), partiendo del supuesto de que el 100 % de la dosis ingerida se excreta en la forma del compuesto original.
English: the concentration of active substance(s)/metabolites of concern in manure/fish faeces following administration of the additive to animals at the proposed dose level. This calculation shall include consideration of dosage rates and amount of excreta produced;
Spanish: la concentración de las sustancias activas o los metabolitos de interés en el estiércol de granja o las heces de los peces tras la administración del aditivo a los animales en la dosis propuesta; en este cálculo se tendrán en cuenta las dosis y la cantidad de excrementos;
Finnish: kyseisten vaikuttavien aineiden tai aineenvaihduntatuotteiden pitoisuus lannassa tai kalojen ulosteissa, kun eläimille on annettu lisäainetta ehdotetulla annostasolla; laskelmissa on otettava huomioon annostustasot ja eritemäärät;
English: Final reports, raw data, study plans and well characterised and identified test substances shall be archived for future reference.
French: Les études doivent être conçues en vue de démontrer l'efficacité de la dose minimale recommandée d'additif en ciblant des paramètres sensibles qui doivent être comparés à un groupe témoin négatif et, éventuellement, positif.
Spanish: Los estudios se diseñarán de modo que se demuestre la eficacia de la dosis mínima de aditivo recomendada, comparando parámetros sensibles con un grupo de referencia negativo y, opcionalmente, con otro positivo.
Hungarian: A végső jelentést, az alapadatokat, a vizsgálati terveket, valamint a jól körülírt és jellemzett tesztelőanyagokat referenciaként meg kell őrizni a jövőre vonatkozóan.
English: Studies shall be designed to demonstrate the efficacy of the lowest recommended dose of additive by targeting sensitive parameters in comparison to a negative and, optionally, a positive control group.
French: Ces études doivent également s'intéresser à la dose maximale recommandée, lorsqu'elle est proposée.
Spanish: Esos estudios incluirán también la dosis máxima recomendada, cuando se proponga.
Hungarian: Az adalékanyagra vonatkozó legalacsonyabb ajánlott adagolás hatékonyságát igazoló vizsgálatokat az érzékeny paramétereket alkalmazva negatív és tetszés szerinti pozitív kontrollcsoporttal összehasonlítva kell megtervezni.
English: Such studies shall also include the maximum recommended dose, where this is proposed. No single design is recommended, flexibility being provided to allow for scientific discretion in the design and conduct of the studies.
French: Aucun plan d'expérience particulier n'est recommandé, une certaine marge d'appréciation étant ainsi laissée sur le plan scientifique pour l'élaboration et la conduite des études.
Spanish: No se recomienda ningún método en particular, sino que los científicos gozarán de la flexibilidad necesaria para diseñar y realizar los estudios como consideren oportuno.
English: reports on adverse effects including accidents (previously unknown effects, severe effects of any type, increased incidence of known effects) for target animals, consumers, users and the environment. The report on adverse effects shall include the nature of the effect, number of affected individuals/organisms, outcome, conditions of use, and causality assessment,
Spanish: informes sobre efectos adversos, incluidos los accidentes (efectos previamente desconocidos, efectos graves de todo tipo, aumento de la incidencia de los efectos conocidos), para los animales destinatarios, los consumidores, los usuarios y el medio ambiente; en el informe sobre los efectos adversos se indicará la naturaleza del efecto, el número de individuos u organismos afectados, el resultado, las condiciones de utilización y la evaluación de la causalidad,
Finnish: raportit haittavaikutuksista, myös onnettomuuksista, (aiemmin tuntemattomista vaikutuksista, kaikista vakavista vaikutuksista, tunnettujen vaikutusten yleistymisestä) kohde-eläimille, kuluttajille, käyttäjille ja ympäristölle; haittavaikutusraportissa on ilmoitettava vaikutustapa, sen kohteena olleiden yksilöiden tai organismien määrä, lopputulos, käyttöolosuhteet sekä arvio syy-seuraussuhteesta,
English: Androulla Vassiliou
Estonian: komisjoni liige
Latvian: Komisijas locekle
English: For Genetically Modified Micro-organisms (GMMs), used as source of additives and grown under contained conditions, Council Directive 90/219/EC applies. A description of fermentation processes (culture medium, fermentation condition and downstream processing of the fermentation products) shall be included.2.3.2.
Estonian: Söödalisandite allikana kasutatud ja kontrollitud tingimustes kasvatatud geneetiliselt muundatud mikroorganismide suhtes kohaldatakse nõukogu direktiivi 90/219/EÜ Lisaks tuleb kirjeldada kääritamisprotsessi (sööde, kääritamistingimused ja käärimissaadustega seotud tootmisahela järgmise etapi töötlusprotsessid).2.3.2.
English: Veterinary medicinal products.
Italian: Medicinali veterinari.
Portuguese: Medicamentos veterinários.
Polish: „Weterynaryjne produkty lecznicze.
Hungarian: Állatgyógyászati termékek.
Slovenian: Zdravila za uporabo v veterinarski medicini.
Estonian: Veterinaarravimid.
Lithuanian: Pranešimas pareiškėjams ir gairės.
English: EMEA/CVMP/153b/97-FINAL.
Italian: EMEA/CVMP/153b/97-DEF.
Dutch: Europees Bureau voor de geneesmiddelenbeoordeling, eenheid Evaluatie van geneesmiddelen voor diergeneeskundig gebruik, EMEA/CVMP/153b/97-FINAL.
Slovak: EMEA/CVMP/153b/97, v konečnom znení.
Hungarian: EMEA/CVMP/153b/97-VÉGLEGES.
Slovenian: EMEA/CVMP/153b/97-KONČ.
Estonian: EMEA/CVMP/153b/97-FINAL. (Juhised lõheliste ja teiste kalade jääkide piirnormide kehtestamiseks. Euroopa Ravimihindamisamet. Veterinaarravimite hindamise osakond.
Lithuanian: EMEA/CVMP/153b/97-GALUTINIS.
English: OJ L 64, 7.3.1987, p. 19. Repealed by Regulation (EC) No 1831/2003.
Finnish: EYVL L 64, 7.3.1987, s. 19. Direktiivi kumottu asetuksella (EY) N:o 1831/2003.
Hungarian: HL L 64., 1987.3.7., 19. o. Hatályon kívül helyezte az 1831/2003/EK rendelet.
Latvian: OV L 64, 7.3.1987., 19. lpp. Atcelta ar Regulu (EK) Nr. 1831/2003.
English: HEALTH AND CONSUMER PROTECTION DIRECTORATE-GENERAL
Finnish: TERVEYS- JA KULUTTAJA-ASIOIDEN PÄÄOSASTO
English: Description of physical and chemical properties shall be given. Dissociation constant, pKa, electrostatic properties, melting point, boiling point, density, vapour pressure, solubility in water and in organic solvents, Kow and Kd/Koc, mass spectrometry and absorption spectra, NMR data, possible isomers and any other appropriate physical properties shall be provided, where appropriate.
Italian: Occorre descrivere le proprietà fisiche e chimiche, indicando, se del caso: costante di dissociazione, pKa, proprietà elettrostatiche, punto di fusione, punto di ebollizione, densità, pressione di vapore, solubilità in acqua e in solventi organici, Kow e Kd/Koc, spettri di massa e di assorbimento, dati RMN, possibili isomeri ed ogni altra opportuna proprietà fisica.
Finnish: Kuvaus aineen fysikaalisista ja kemiallisista ominaisuuksista, joista ilmoitetaan dissosiaatiovakio, pKa, elektrostaattiset ominaisuudet, sulamispiste, kiehumispiste, tiheys, höyrynpaine, liukoisuus veteen ja orgaanisiin liuottimiin, Kow- ja Kd/Koc-arvo, massa- ja absorptiospektri, NMR-spektri, mahdolliset isomeerit sekä tarvittaessa muut olennaiset fysikaaliset ominaisuudet.
English: poultry 6; salmonids and other fish 10.
Finnish: siipikarja: 6,
Hungarian: baromfifajok 6,
Lithuanian: naminiai paukščiai – 6,
English: products:milk 8 samples per time point; eggs 10 eggs per time point;
Finnish: lohikalat ja muut kalat: 10.
Hungarian: lazacfélék és egyéb halfajok 10.
Lithuanian: lašišinės ir kitos žuvys – 10.
English: Has the additive a PEC in surface water ≥ 0,1 µg/l or PEC sediment ≥ 10 µg/ kg? NO
Finnish: Arviovaihe II Vaiheen II tarkoituksena on arvioida lisäaineiden mahdollisia vaikutuksia muihin kuin kohde-eläinlajeihin ympäristössä, sekä vesi- että maaeläinlajeihin, tai mahdollista päätymistä pohjaveteen liiallisina määrinä.
English: YES NO YES
Finnish: Ei ole järkevää arvioida lisäaineiden vaikutuksia kaikkiin sellaisiin eläinlajeihin ympäristössä, jotka voivat altistua lisäaineelle sen jälkeen, kun sitä on annettu kohde-eläimille. Testattujen taksonomisten tasojen on tarkoitus toimia malleina tai indikaattoreina ympäristön eläinlajistolle.
English: PHASE II STOP
French: Phase II
Finnish: PNEC-arvo on laskettava kullekin olennaiselle lokerolle.
English: Phase II assessment The aim of Phase II is to assess the potential for additives to affect non-target species in the environment, including both aquatic and terrestrial species or to reach groundwater at unacceptable levels. It is not practical to evaluate the effects of additives on every species in the environment that may be exposed to the additive following its administration to the target species. The taxonomic levels tested are intended to serve as surrogates or indicators for the range of species present in the environment. The Phase II assessment is based on a risk quotient approach, where the calculated PEC and Predicted No Effect Concentration (PNEC) values for each compartment shall be compared. The PNEC is determined from experimentally determined endpoints divided by an appropriate assessment factor. The PNEC value shall be calculated for each compartment. The Phase II assessment starts with a refinement of the PEC if possible, and uses a two-tiered approach to the environmental risk assessment. The first tier, Phase IIA, makes use of a limited number of fate and effect studies to produce a conservative assessment of risk based on exposure and effects in the environmental compartment of concern.
Finnish: Jos PEC-arvon suhde PNEC-arvoon on alle 1, lisäarviota ei tarvita, ellei biokertyminen ole todennäköistä.
English: Phase II A In addition to the compartments considered in Phase I, the PEC for surface water has to be calculated considering runoff and drainage. Based on data not considered in Phase I, a more refined PEC can be calculated for each environmental compartment of concern. In ascertaining the refined PEC, account shall be taken of:
Finnish: Kullekin kyseeseen tulevalle ympäristölokerolle voidaan laskea tarkempi PEC-arvo niiden tietojen perusteella, joita ei otettu huomioon vaiheessa I. Tarkempaa PEC-arvoa varmistettaessa on otettava huomioon seuraavat tekijät:
English: The European Agency for the Evaluation of Medicinal Products. Veterinary Medicines Evaluation Unit.
Finnish: Euroopan lääkearviointivirasto (The European Agency for the Evaluation of Medicinal Products), Veterinary Medicines Evaluation Unit.
English: From 60-120 days Up to 120-250 days (or according to local custom)
Finnish: 120–250 päivän ikäiseksi saakka (tai paikallisen käytännön mukaisesti)
English: For chemically defined compound used as flavourings, the FLAVIS number in connection with relevant chemical group shall be included. For plant extracts the phytochemical markers must be included.
French: Pour les composés chimiquement définis utilisés comme arômes, il convient d'ajouter le numéro FLAVIS correspondant au groupe chimique concerné et, pour les extraits végétaux, les marqueurs phytochimiques.
English: 14 days Preferably from 14 days to weaning
French: De préférence de l'âge de 14 jours jusqu'au sevrage
English: In certain situations (e.g. some nutritional and sensory additives or additives intended for minor species) it may be appropriate to subsequently refine the human exposure assessment using more realistic consumption figures, but still keeping the most conservative approach. Where this is possible this shall be based on Community data.
French: Dans certaines situations (par exemple certains additifs nutritionnels et sensoriels ou des additifs destinés à des espèces mineures), il peut s'avérer utile d'affiner encore l'évaluation de l'exposition humaine à l'aide de chiffres de consommation plus réalistes, tout en gardant l'approche la plus conservatrice, en se fondant, si possible, sur des données communautaires.
English: The Phase II assessment is based on a risk quotient approach, where the calculated PEC and Predicted No Effect Concentration (PNEC) values for each compartment shall be compared. The PNEC is determined from experimentally determined endpoints divided by an appropriate assessment factor. The PNEC value shall be calculated for each compartment.
French: La phase II de l'évaluation commence par un affinement de la CPE, lorsque cela est possible, et suit une approche en deux étapes de l'évaluation du risque pour l'environnement.
English: The Phase II assessment starts with a refinement of the PEC if possible, and uses a two-tiered approach to the environmental risk assessment. The first tier, Phase IIA, makes use of a limited number of fate and effect studies to produce a conservative assessment of risk based on exposure and effects in the environmental compartment of concern.
French: La première étape, la phase II A, a recours à un nombre limité d'études du devenir et des effets afin d'obtenir une évaluation conservatrice du risque lié à l'exposition et des effets dans le milieu de l'environnement concerné.
English: For all groups of flavourings, the relevant identification number(s) (such as FLAVIS, Council of Europe, JECFA, CAS or any other internationally accepted numbering system) used specifically for the identification of flavouring products in feed and food shall always be provided when available. (1) Natural products — botanically defined
French: Pour tous les groupes d'arômes, le ou les numéros d'identification pertinents [comme le numéro FLAVIS, le numéro du Conseil de l'Europe, le numéro JECFA, le numéro CAS ou tout autre système de numérotation accepté au niveau international] spécifiquement utilisé(s) pour identifier les produits aromatisants dans l'alimentation animale et dans les denrées alimentaires doivent toujours être mentionnés s'ils sont disponibles.1) Produits naturels — de constitution botanique définie
Polish: W przypadku wszystkich grup środków aromatyzujących należy podać (jeśli jest dostępny) odpowiedni numer lub numery identyfikacyjne (na przykład FLAVIS, Rady Europy, JECFA, CAS lub innego uznanego na świecie systemu numeracji) stosowanego konkretnie do identyfikacji środków aromatyzujących w paszach i żywności.1) Produkty naturalne – zdefiniowane botanicznie
English: Method of production and manufacture The whole of the subsection 2.3 of Annex II applies.
French: Méthode de production et de fabrication
English: In the case of non chemically well defined natural products, usually complex mixtures of many compounds obtained by an extraction process, a detailed description of the extraction process shall be provided. It is recommended to use in the description the relevant terminology such as essential oil, absolute, tincture, extract and related terms widely used for botanically defined flavouring products to describe the extraction process.
French: Tout le sous-chapitre 2.3 de l'annexe II s'applique.
English: The extraction solvents used shall be specified, the precautions taken to avoid residues of the solvents, and the levels of residues where these are of toxicological concern if their presence would be unavoidable. The terms used to characterise the extract may include a reference to the method of extraction.2.2.2.3.
French: Dans le cas de produits naturels dont la constitution chimique n'est pas bien définie, généralement des mélanges complexes de nombreux composés obtenus par extraction, le procédé d'extraction doit être décrit en détail.
English: Methods of analysis (1) For natural products (either botanically defined or non-plant origin) which do not contain substances of toxicological concern for humans or animals, the standard requirement for methods of analysis of subsection 2.6 of Annex II may be replaced by a simpler qualitative method of analysis fit for the purpose for major or characteristic components of the product.
French: Il est recommandé d'utiliser dans la description la terminologie pertinente [par exemple huile essentielle, absolu, teinture, extrait et termes apparentés ] couramment utilisée pour les produits aromatisants de constitution botanique définie afin de décrire le procédé d ' extraction.
English: Section I: summary of the dossier The whole of Section I of Annex II applies. 7.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis The Section II of Annex II applies as following:
French: Chapitre I: résumé du dossier
English: Section II: identity, characterisation and conditions of use of the additive; methods of analysis The Section II of Annex II applies as following:
French: Chapitre II: identité, caractérisation et conditions d'utilisation de l'additif; méthodes d'analyse
English: Section I: summary of the dossier The whole of Section I of Annex II applies. 11.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis
French: Chapitre I: résumé du dossier
English: inhalation tests in laboratory animals; published epidemiological data and/or the applicants own data on its work plant and/or irritancy; and
Hungarian: az irodalomban megjelent epidemiológiai adatokra és/vagy a kérelmező üzeméből származó saját adatokra és/vagy az irritációra, és
English: Directive as last amended by Directive 2006/121 of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 852; corrected by OJ L 136 29.5.2007, p. 281). [3] OJ L 152, 30.4.2004, p. 1; corrected by OJ L 216, 16.6.2004, p. 3.
Hungarian: HL L 196., 1967.8.16., 1. o. Legutóbb a 2006/121/EK európai parlamenti és tanácsi irányelvvel (HL L 396., 2006.12.30., 852. o.) módosított irányelv; helyesbítve: HL L 136., 2007.5.29., 281. o.
English: OJ L 221, 17.8.2002, p. 8. Decision as last amended by Decision 2004/25/EC (OJ L 6, 10.1.2004, p. 38).
Hungarian: HL L 221., 2002.8.17., 8. o. A legutóbb a 2004/25/EK határozattal (HL L 6., 2004.1.10., 38. o.) módosított határozat.
Latvian: OV L 221, 17.8.2002., 8. lpp. Lēmumā jaunākie grozījumi izdarīti ar Lēmumu 2004/25/EK (OV L 6, 10.1.2004., 38. lpp.).
English: The identification of the additive shall contain a summary of the information required according to Annex II or III, depending on the type of the feed additive authorisation. In particular: name of the additive, proposed classification by category and functional group, target species/animal categories and doses.
Italian: L'identificazione dell'additivo deve contenere una sintesi delle informazioni richieste a norma dell'allegato II o III, a seconda del tipo di autorizzazione dell'additivo per mangimi. in particolare: nome dell'additivo, classificazione proposta per categoria e per gruppo funzionale, specie/categorie di animali bersaglio e dosi.
Lithuanian: Priedo identifikavimą sudaro informacijos, kurią būtina pateikti pagal II arba III priedus atsižvelgiant į pašarų priedo leidimo tipą, santrauka, visų pirma priedo pavadinimas, siūloma klasifikacija pagal kategorijas ir funkcines grupes, tikslinės rūšys/gyvūnų kategorijos ir dozės.
English: A scientific summary including details of each part of the documents submitted to support the application, according to this Annex and Annex III shall be submitted. This summary shall include the conclusions made by the applicant(s).
Italian: Va presentata una sintesi scientifica che include dettagli di ogni parte dei documenti presentati a corredo della domanda, conformemente al presente allegato e all'allegato III, nonché le conclusioni dei richiedenti.
English: 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. A material safety data sheet of chemicals used in the production process shall be provided.
Italian: Per definire i punti critici del processo che potrebbero influire sulla purezza dei principi attivi/agenti o di un additivo occorre descrivere il processo di produzione, allegando la scheda dei dati di sicurezza dei prodotti chimici usati in tale processo.
English: 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. Possible contra-indications shall be mentioned.
Italian: Le specie o categorie animali, il gruppo di età o la fase di produzione degli animali vanno indicati conformemente alle categorie di cui all'allegato IV del presente regolamento, insieme alle possibili controindicazioni.
English: 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. In particular, the methods shall meet at least one of the requirements mentioned in 2.6.1.1.
Italian: Tali metodi devono rispettare le stesse prescrizioni applicabili ai metodi di analisi utilizzati per i controlli ufficiali di cui all'articolo 11 del regolamento (CE) n. 882/2004 e devono soddisfare in particolare almeno uno dei requisiti di cui al punto 2.6.1.1.
Swedish: Dessa metoder ska uppfylla de krav som gäller för de analysmetoder som används vid offentliga kontroller enligt artikel 11 i förordning (EG) nr 882/2004, särskilt minst ett av de krav som anges i 2.6.1.1.
English: In order to reduce the number and the suffering of the animals involved, new protocols for acute dose toxicity testing are continually being developed. Studies carried out by these new procedures will be accepted, when properly validated.
Italian: Al fine di ridurre il numero e le sofferenze degli animali trattati si sviluppano continuamente nuove norme per questo tipo di prove; gli studi condotti con queste nuove procedure saranno accettati se correttamente convalidati.