FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: 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.
Italian: Vista l'impraticabilità di valutare gli effetti degli additivi su ogni specie nell’ambiente potenzialmente esposta ad un additivo in seguito alla sua somministrazione alla specie bersaglio, i livelli tassonomici testati devono servire da surrogati o indicatori per le varie specie presenti nell'ambiente.
English: For those additives where, following Phase IIA assessment, an environmental risk cannot be excluded, more information is required on the effects on biological species in the environmental compartment(s) in which Phase IIA studies indicate possible concern. In this situation, further tests are needed to determine the chronic and more specific effects on appropriate microbial, plant, and animal species.
Italian: Per gli additivi per i quali, in seguito ad una valutazione di fase II A, non può essere escluso un rischio ambientale, sono necessarie ulteriori informazioni riguardanti gli effetti sulle specie biologiche nei comparti ambientali considerati potenzialmente a rischio in base agli studi della fase II A. In questa situazione occorrono ulteriori test per determinare gli effetti cronici e più specifici su specie animali, vegetali e microbiche idonee.
English: 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. The composition of the fermentation/cultivation media shall be provided.
Lithuanian: Pateikiamas gamybos proceso (pvz., cheminės sintezės, fermentacijos, auginimo, išskyrimo iš organinės medžiagos arba distiliavimo), naudojamo ruošiant priedo veikliąją (-iąsias) medžiagą (-as) ir (arba) agentą (-us), aprašas, prireikus struktūrinės schemos pavidalu.
English: Concentration shall be adjusted by reducing the amount of carrier present but the ratio of active agent(s)/substance(s) to the other fermentation products must remain the same as in the final product. For enzymes, the diet shall provide the appropriate substrate(s).
Lithuanian: Ši koncentracija derinama mažinant esančios nešamosios medžiagos kiekį, bet veikliosios (-iųjų) medžiagos (-ų) ir kitų fermentacijos produkcijos santykis galutiniame produkte turi išlikti toks pat. Tiriant fermentus, pašare turi būti atitinkamo substrato (-ų).
English: OJ L 196, 16.8.1967, p. 1. 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).
Latvian: OV L 196, 16.8.1967., 1. lpp. Direktīvā jaunākie grozījumi izdarīti ar Eiropas Parlamenta un Padomes Direktīvu 2006/121/EK (OV L 396, 30.12.2006., 852. lpp.; labota ar OV L 136, 29.5.2007., 281. lpp.).
English: Where appropriate, the compliance with the requirement of efficacy provided for in Article 5(3) of Regulation (EC) No 1831/2003 may be demonstrated by submission of material other than studies, in particular relating to the long history of use. 11.5. Section V: post-market monitoring plan
Latvian: V iedaļa – plāns realizēto preču uzraudzībai
English: The general procedures of the analytical methods to be used for the analysis for the official controls of the additive as such, in premixtures, and in feedingstuffs, as required in this Annex and Annex III shall be described. If appropriate, on the basis of the information submitted in this Annex and Annex III, the procedure of the method(s) to be used for the analysis for the official controls of the additives or its metabolites in food of animal origin shall be included.
Dutch: Er moet een beschrijving worden gegeven van de algemene procedures van de analysemethoden voor de officiële controles op het toevoegingsmiddel als zodanig in voormengsels en in diervoeders, zoals voorgeschreven in deze bijlage en bijlage III. Op basis van de informatie die overeenkomstig deze bijlage en bijlage III wordt ingediend, moet in voorkomend geval ook de procedure van de methode(n) voor de officiële controles op het toevoegingsmiddel of metabolieten daarvan in voedsel van dierlijke oorsprong worden beschreven.
English: Is the additive intended for non-food producing animals only? NO
Dutch: Is het toevoegingsmiddel alleen bestemd voor niet-voedselproducerende dieren?
English: Special attention shall be given to impurities as mentioned in subsection 2.1.4 of Annex II. The concentrations of substances of toxicological concern for humans or animals which may occur in the plant from which the extract is produced shall also be reported. The pharmacological or related properties of the plant of origin, its parts or of derived products thereof shall be fully investigated and reported.
Dutch: Er moet speciale aandacht worden besteed aan onzuiverheden zoals bedoeld in subsectie 2.1.4 van bijlage II. De eventuele concentratie aan stoffen die van toxicologisch belang zijn voor mens of dier in de plant waaruit het extract wordt vervaardigd, moet eveneens worden vermeld.De farmacologische of aanverwante eigenschappen van de plant van oorsprong, de delen daarvan of de daarvan afgeleide producten moeten grondig worden onderzocht en worden vermeld.
English: Where no such link can be made, efficacy shall be demonstrated following the general rules for Section IV in Annex II. In some cases it may be appropriate to combine animal species in the same productive stage (e.g. goats and sheep used for milk production).
Dutch: Indien geen dergelijk verband kan worden gelegd, moet de werkzaamheid worden aangetoond volgens de algemene voorschriften van sectie IV van bijlage II. In sommige gevallen kan het aangewezen zijn diersoorten in hetzelfde productiestadium te combineren (bv. geiten en schapen voor melkproductie).
English: The measured values for TRC and MRC shall be inserted as appropriate in the template shown in Table 3, and the other values calculated. Where a full data set is not available because values fall below the limit of detection (LOD), an extrapolation of RMTR may be acceptable.
Portuguese: Quadro 3
English: Deriving an MRL can only be performed if the sum of the individual DITRs is below the ADI. If the ADI is exceeded, an alternative would be to use data from a longer withdrawal time or lower dosages.
Portuguese: Modelo para definir uma proposta de LMR
English: A first proposal for an MRL can be obtained using the MRC value as a guide and taking into consideration the LOQ of the analytical method. The sum of the DITRMRL obtained from the proposed MRLs must be below the ADI and close to the sum of the individual DITRs. If the ADI is exceeded, then a lower MRL shall be proposed and the comparison repeated.
Portuguese: Fígado
English: For certain additives, residues could arise below the MRL values in milk, eggs or meat which could nonetheless interfere with food quality in particular food processing procedures. For such additives, it may be appropriate to consider a ‘maximum (food product) processing compatible residue’ (MPCR) in addition to establishing MRL values.
Portuguese: Rim
English: Skin + fat Milk Eggs Honey Sum
Portuguese: Soma
English: ANNEX III SPECIFIC REQUIREMENTS TO BE SATISFIED BY THE DOSSIER PROVIDED FOR IN ARTICLE 3 WITH RESPECT TO CERTAIN CATEGORIES OF ADDITIVES OR CERTAIN PART ICULAR SITUATIONS, AS PROVIDED FOR IN ARTICLE 7(5) OF REGULATION (EC) No 1831/2003
Portuguese: REQUISITOS ESPECÍFICOS A SATISFAZER PELO PROCESSO PREVISTO NO ARTIGO 3.o NO QUE DIZ RESPEITO A CERTAS CATEGORIAS DE ADITIVOS OU CERTAS SITUAÇÕES PARTICULARES, TAL COMO PREVISTO NO N.o 5 DO ARTIGO 7.o DO REGULAMENTO (CE) N.o 1831/2003
English: If the active substance is present in a fermentation product, the fermentation product shall be tested. The fermentation product tested must be identical to that to be used in the commercial product.
Slovak: Ak je účinná látka prítomná vo fermentačnom produkte, testovaný fermentačný produkt musí byť rovnaký ako produkt použitý v predávanom výrobku.
English: 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. 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.
Swedish: De ska ha validerats internt i enlighet med internationella harmoniserade riktlinjer för intern validering av analysmetoder med avseende på de kriterier som anges i 2.6.1.2.2.6.1.2 Den detaljerade karakteriseringen av metoderna ska omfatta de lämpliga kriterier som anges i bilaga III till förordning (EG) nr 882/2004.
English: For the other additives a second phase (Phase II) assessment is needed to provide additional information, based upon which further studies may be considered necessary. These studies shall be conducted according to Directive 67/548/EEC.
Swedish: För övriga tillsatser behövs det en andra bedömningsfas (fas II) för att få fram ytterligare information och utifrån denna avgörs om det behövs ytterligare studier som ska genomföras i enlighet med direktiv 67/548/EEG.
English: 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:
Swedish: En noggrannare beräkning av PEC-värdet kan göras för varje berört miljöområde baserad på uppgifter som inte beaktats under fas I. Vid fastställandet av ett noggrannare PEC-värde ska hänsyn tas till följande punkter:
English: For all technological and some sensory additives affecting the characteristics of feed, efficacy shall be demonstrated using a laboratory-based study. The study shall be designed to cover a representative range of materials to which the additive will be applied.
Swedish: För alla tekniska tillsatser och en del organoleptiska tillsatser som påverkar fodrets egenskaper ska effektiviteten påvisas genom en laboratoriebaserad studie.
English: Section III subsections 3.2 and 3.4 of Annex II apply. (3) For substances which favourably affect the colour of ornamental fish or birds, studies concerning Section III subsection 3.1 of Annex II are required and shall be performed on animals receiving the additive at the recommended dose. Evidence can also be provided by reference to existing scientific literature. However, subsections 3.2 and 3.4 are not required.
Swedish: Punkterna 3.2 och 3.4 i bilaga II behöver dock inte tillämpas.
English: Where no such link can be made, efficacy shall be demonstrated following the general rules for Section IV in Annex II. In some cases it may be appropriate to combine animal species in the same productive stage (e.g. goats and sheep used for milk production). Significance should be demonstrated in each study (P ≤ 0,1) or, if possible, by meta-analysis (P ≤ 0,05). If efficacy demonstration is required, the duration of efficacy studies shall be analogous to the comparable production stages of the physiologically comparable major species. In other cases, the minimum study duration shall follow the relevant provisions in subsection 4.4 of Annex II and Annex IV.
Swedish: I andra fall ska studiernas minimilängd överensstämma med tillämpliga bestämmelser i punkt 4.4 i bilaga II och bilaga IV.
English: 42 days Breeding does (for reproduction)
Swedish: Tabell 8.
English: Two cycles (if the reproduction parameters are requested). Breeding does (in order to have benefits to young rabbits)
Swedish: Definition av djurkategori
English: At least 2 weeks before parturition until the end of the weaning period (e.g. for micro-organism product)
Swedish: Minimilängd för långsiktiga effektivitetsstudier
English: Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Horses All categories
Swedish: Samtliga kategorier