FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases a justification, acceptable to the competent authority must be submitted. Such a justification may be the existence of a frame-formulation to which the applicant has the right of access.
Greek: Δεν είναι ανάγκη να παρέχονται πληροφορίες οι οποίες δεν είναι απαραίτητες λόγω της φύσεως του βιοκτόνου ή των προτεινόμενων χρήσεών του. Το αυτό ισχύει και όταν η παροχή των πληροφοριών δεν είναι επιστημονικώς αναγκαία ή τεχνικώς εφικτή. Στις περιπτώσεις αυτές, πρέπει να αναφέρονται οι σχετικοί λόγοι και να γίνουν αποδεκτοί από τις αρμόδιες αρχές. Σχετικό λόγο μπορεί να συνιστά και η ύπαρξη ομαδικής τυποποίησης στην οποία ο αιτών έχει δικαίωμα πρόσβασης.
English: Products used for the disinfection of air, surfaces, materials, equipment and furniture which are not used for direct food or feed contact in private, public and industrial areas, including hospitals, as well as products used as algaecides. Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air-conditioning systems;
Greek: Προϊόντα για την απολύμανση του αέρα, των επιφανειών, των υλικών του εξοπλισμού και της επίπλωσης που δεν έρχονται σε άμεση επαφή με τα τρόφιμα ή τις ζωοτροφές σε ιδιωτικούς, δημόσιους και βιομηχανικούς χώρους, περιλαμβανομένων των νοσοκομείων, καθώς και προϊόντα χρησιμοποιούμενα ως φυκοκτόνα αλγεοκτόνα.
English: Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied. These models shall:
Greek: Όταν για τον προσδιορισμό των επιπέδων έκθεσης χρησιμοποιούνται υπολογιστικές μέθοδοι, εφαρμόζονται κατάλληλα μοντέλα, τα οποία πρέπει:
English: Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied. The characteristics of these models shall be as listed in paragraph 33.
Greek: Όταν για τον προσδιορισμό των επιπέδων έκθεσης χρησιμοποιούνται υπολογιστικές μέθοδοι, εφαρμόζονται κατάλληλα μοντέλα, τα οποία πρέπει να έχουν τα χαρακτηριστικά που αναφέρονται στο σημείο 33.
English: This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated.
Greek: Συμπεριλαμβάνεται εν προκειμένω αξιολόγηση του μηχανισμού που επιφέρει το σκοπούμενο αποτέλεσμα και των παρατηρούμενων συνεπειών επί της συμπεριφοράς και της υγείας των σπονδυλωτών στόχων 7 εάν το σκοπούμενο αποτέλεσμα είναι η θανάτωση του σπονδυλωτού στόχου, εκτιμάται ο χρόνος που χρειάζεται για να επέλθει ο θάνατος του σπονδυλωτού-στόχου και οι συνθήκες υπό τις οποίες επέρχεται.
English: If the conclusion arrived at by the Member State is that additional information or data are required before an authorisation decision can be made, then the need for any such information or data shall be justified. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.
Greek: Αν το κράτος μέλος καταλήξει στο συμπέρασμα ότι χρειάζεται περισσότερες πληροφορίες ή δεδομένα για να είναι σε θέση να αποφασίσει, αιτιολογεί την αναγκαιότητα αυτών των συμπληρωματικών πληροφοριών ή δεδομένων, τα οποία πρέπει να περιορίζονται στα ελάχιστα απαραίτητα για τη διενέργεια της ενδεδειγμένης περαιτέρω εκτίμησης κινδύνου.
English: The inclusion in Annex I, IA or IB of an active substance shall be restricted to those product types in Annex V for which relevant data have been submitted in accordance with Article 8. 4.
Portuguese: A inclusão de uma substância activa nos anexos I, I A ou I B restringir-se-á aos tipos de produtos previstos no anexo V relativamente aos quais tenham sido apresentados dados relevantes, em conformidade com o artigo 8º 4.
English: Renewal may, where necessary, be granted only for the minimum period necessary to complete a review, where an application has been made for such renewal, and shall be granted for the period necessary to provide further information requested in accordance with Article 11(2). 5.
Portuguese: A renovação poderá, se for caso disso, ser concedida apenas pelo período mínimo necessário à conclusão da revisão, no caso de ter sido apresentado o respectivo pedido, e será concedida pelo período necessário ao fornecimento das informações adicionais requeridas ao abrigo do nº 2 do artigo 11º
English: A decision to remove an Annex I entry shall not have immediate effect but shall be delayed for a period of up to a maximum of four years from the date of that decision. Article 11 Procedure for inclusion of an active substance in Annex I, IA or IB 1.
Lithuanian: Sprendimas išbraukti įrašą iš I priedo neįsigalioja tuoj pat, bet atidedamas ne ilgesniam kaip ketverių metų laikotarpiui nuo jo priėmimo dienos. 11 straipsnis Veikliosios medžiagos įrašymo į I, IA arba IB priedus tvarka
English: The receiving competent authority shall, within 12 months of accepting the dossiers, carry out an evaluation thereof. A copy of the evaluation shall be sent by the competent authority to the Commission, the other Member States and to the applicant, together with a recommendation for the inclusion, or otherwise, of the active substance in Annex I, IA or IB. If, when the dossiers are evaluated, it appears that further information is necessary for full evaluation to be made, the receiving competent authority shall ask that the applicant submit such information.
Lithuanian: Gaunančioji kompetentinga institucija, per 12 mėnesių nuo dokumentų gavimo dienos, juos įvertina. Įvertinimo kopiją ir rekomendaciją dėl veikliosios medžiagos įrašymo arba neįrašymo į I, IA arba IB priedus ji nusiunčia Komisijai, kitoms valstybėms narėms ir pareiškėjui. Jei įvertinus dokumentus paaiškėja, kad nuodugniam vertinimui reikia daugiau informacijos, gaunančioji kompetentinga institucija paprašo pareiškėjo tokią informaciją pateikti.
English: in the case of an active substance not on the market on the date referred to in Article 34(1), for a period of 15 years from the date of first inclusion in Annex I or IA, or (c) in the case of an active substance already on the market on the date referred to in Article 34(1):
Lithuanian: kai 34 straipsnio 1 dalyje nurodytą dieną veiklioji medžiaga jau 15 metų nuo jos pirmojo įrašymo į I arba IA priedus nebuvo rinkoje, arba c) kai veiklioji medžiaga 34 straipsnio 1 dalyje nurodytą dieną rinkoje buvo jau:
English: in the case of any data submitted for the first time for either of the following: (i) variation of the conditions of authorisation of a biocidal product; (ii) submission of data necessary to maintain entry of an active substance onto Annex I or IA for a period of five years from the date of first receipt of further information, unless the five-year period expires before the period in paragraphs (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.
Lithuanian: kai bet kokie vėlesni duomenys pirmą kartą buvo pateikti: i) keičiant biocidinio produkto autorizacijos sąlygas; ii) pateikiant duomenis, būtinus norint išlaikyti veikliąją medžiagą I arba IA priede penkeriems metams nuo dienos, kurią pirmą kartą buvo gauta papildoma informacija, nebent penkerių metų laikotarpis pasibaigtų anksčiau už šio straipsnio 1 dalies b ir c punktuose nurodytą, ir tada jis būtų pratęstas tiek, kad abiejų laikotarpių pabaiga sutaptų.
English: The President J. M. GIL-ROBLES
Lithuanian: Pirmininkas J. M. Gil-Robles
English: Summary and evaluation of Sections II to IX The following data will be required to support submission on the above points.
Lithuanian: II–IX skyrių santrauka ir įvertinimas Toliau pateikta informacija bus reikalinga pirmiau nurodytai informacijai pagrįsti.
English: Taxonomic name and strain indicating whether it is a stock variant or a mutant strain; for viruses, taxonomic designation of the agent, serotype, strain or mutant
Greek: Ονομασία ταξινόμησης και στέλεχος, με τη διευκρίνιση εάν πρόκειται για συνήθη παραλλαγή ή για μεταλλαγμένο στέλεχος 7 όσον αφορά τους ιούς, ταξινομική περιγραφή του παράγοντα, του οροτύπου, του στελέχους ή του μεταλλάκτη
Lithuanian: Taksonominis pavadinimas ir padermė, nurodant, ar tai yra kolekcinis kamienas, ar mutantinė padermė, virusų – taksonominė priklausomybė, serotipas, padermė ar mutantas.
English: Chronic toxicity Two species, rodent and one other mammal, oral administration unless another route is more appropriate
Lithuanian: Lėtinis toksiškumas Naudojant dvi rūšis: graužikus ir dar vieną žinduolių rūšį; tyrimai atliekami suleidžiant tiriamąją medžiagą per virškinimo traktą, išskyrus tuos atvejus, kai tinkamesnis yra kitas suleidimo būdas.
English: Mutagenicity studies As specified in Annex IIA, Section VI, part 6.6
Lithuanian: Mutageniškumo tyrimai Kaip nurodyta IIA priedo, VI skirsnio 6.6 dalyje.
English: Teratogenicity test - rabbit and one rodent species. Fertility study - one species, minimum of two generations, male and female
Lithuanian: Teratogeniškumo tyrimas naudojant triušius ir dar vieną graužikų rūšį. Vaisingumo tyrimas – naudojant vieną gyvuliukų rūšį, mažiausiai dviejų kartų, patiną ir patelę.
English: Neurotoxicity studies: required where there is any indication of anticholinerterase activity or other neurotoxic effects. Delayed neurotoxicity tests using adult hens should be performed where appropriate
Lithuanian: Neurotoksiškumo tyrimai, kai turima duomenų apie galimą veikliosios medžiagos anticholinesterazinį poveikį arba neurotoksiškumą. Prireikus turėtų būti atliekami atokiojo neurotoksiškumo tyrimai naudojant vištas.
English: ANNEX VI COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS DEFINITIONS
Lithuanian: VI PRIEDAS BENDRIEJI BIOCIDINIŲ PRODUKTŲ DOKUMENTŲ VERTINIMO PRINCIPAI TURINYS SĄVOKŲ APIBRĖŽIMAI
English: Dose (concentration) - response (effect) assessment This is the estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
Lithuanian: Dozės (koncentracijos)-atsako (reakcijos) įvertinimas Ryšio tarp veikliosios arba svarbiosios medžiagos dozės (koncentracijos per tam tikrą laiką) ir atsako (reakcijos) masto bei dažnio įvertinimas.
English: the physical properties of the biocidal product, - the benefits of using the biocidal product.
Lithuanian: Prieš išduodama autorizaciją valstybė narė patvirtina, kad šie reikalavimai būtų patenkinti.
English: Such a justification may be the existence of a frame-formulation which the applicant has the right to access. 6.
Romanian: Această justificare poate fi existența unei formulări-cadru la care solicitantul are drept de acces.
English: Cooperation in the use of data for second and subsequent applications for authorisation 1.
Romanian: Cooperarea pentru utilizarea informațiilor la a doua cerere precum și la cererile de autorizare ulterioare
English: I. Applicant
Romanian: I. Solicitant
English: V. Effectiveness against target organisms and intended uses
Romanian: V. Eficacitate contra organismelor țintă și utilizări preconizate
English: I. APPLICANT
Romanian: I. SOLICITANT
English: V. EFFECTIVENESS AGAINST TARGET ORGANISMS AND INTENDED USES
Romanian: V. EFICACITATEA CONTRA ORGANISMELOR ȚINTĂ ȘI UTILIZĂRI PRECONIZATE
English: For the following studies,
Romanian: Pentru următoarele studii,
English: (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of administration is the oral route unless it can be justified that an alternative route is more appropriate
Romanian: (dacă este cazul), 6.4, 6.5, 6.7 și 6.8, calea de administrare impusă este cea orală, cu excepția justificării unei alte căi alternative care să fie mai potrivită.
English: Inherent biodegradability, where appropriate 7.6.2.
Romanian: 7.6.1.2.Biodegrabilitate intrinsecă, dacă este cazul
English: V. Intended uses of the biocidal product and efficacy for these uses
Romanian: V. Utilizări preconizate ale produsului biodestructiv și eficacitate
English: V. INTENDED USES AND EFFICACY
Romanian: V. UTILIZĂRI PRECONIZATE ȘI EFICACITATE
English: industrial, professional, general public (non-professional) Efficacy data
Romanian: industrial, profesional, populație (ne-profesional)
English: Procedures, if any, for cleaning application equipment 8.4.
Romanian: Dacă există, proceduri de curățare a echipamentului utilizat pentru aplicații
English: Any other biodegradability tests that are relevant from the results in paragraphs 7.6.1.1 and 7.6.1.2 of Annex IIA 5.
Romanian: Orice alte teste de biodegradabilitate care sunt relevante prin rezultatele obținute la pct. 7.6.1.1 și 7.6.1.2 din anexa II A
English: Fate and behaviour in water 2.1.
Romanian: Evoluția și comportamentul în apă
English: Summary and evaluation of parts 1, 2, 3 and 4 (1)
Romanian: Rezumat și evaluare a pct. 1, 2, 3 și 4
English: I. Applicant details
Romanian: I. Solicitant
English: V. Biological properties of active organism including pathogenicity and infectivity for target and non-target organisms including man
Romanian: V. Proprietăți biologice ale organismului activ, inclusiv efectele patogene și infecțioase pentru organismele țintă și expuse neintenționat, inclusiv pentru om
English: V. BIOLOGICAL PROPERTIES OF THE ORGANISM
Romanian: V. PROPRIETĂȚI BIOLOGICE ALE ORGANISMULUI
English: V. Intended uses and efficacy for those uses
Romanian: V. Utilizări preconizate și eficacitate
English: V. INTENDED USES AND EFFICACY FOR THESE USES
Romanian: V. UTILIZĂRI PRECONIZATE ȘI EFICACITATE
English: Re-entry periods, necessary waiting periods or other precautions to protect humans and animals 8.3.
Romanian: Perioade de reintroducere, perioade de așteptare necesare sau alte măsuri de precauție destinate protecției omului și animalelor
English: I. With regard to non-biological components of the product in accordance with Directive 88/379/EEC
Romanian: I. Cu privire la compușii nonbiologici ai produsului în conformitate cu Directiva 88/379/CEE
English: the frequency and duration of exposure, - the type and size of specific exposed populations where such information is available.
Romanian: frecvența și durata expunerii; tipul și dimensiunea populațiilor specifice expuse pentru care sunt disponibile astfel de informații.
English: data on structurally analogous substances, - endocrine effects.
Romanian: datele despre substanțe analoge structural; efecte endocrine.
English: If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of exposure. Unacceptable effects
Romanian: Dacă nu este posibilă stabilirea unui raport PEC / PNEC, caracterizarea riscurilor implică o evaluare cantitativă a probabilității de producere a unui efect în condițiile actuale de expunere sau în viitor, în condițiile de expunere prevăzute.